Manufacturer's Devices - SYNTHES GMBH

Address:




EIMATTSTRASSE 3



4436 OBERDORF

n/a

Switzerland


Authorised Representative/ UK Responsible Person
Name: Johnson & Johnson Medical Ltd
Address:

Baird House 4 Lower Gilmore Bank



Edinburgh

EH3 9QP

Scotland United Kingdom




Code/Term Type
Tibia nail sterileTibia nail sterileClass III
Orthopaedic bone nutOrthopaedic bone nutClass III
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass III
Orthopaedic fixation plate bioabsorbableOrthopaedic fixation plate bioabsorbableClass III
Orthopaedic bone boltOrthopaedic bone boltClass IIb
Orthopaedic bone boltOrthopaedic bone boltClass III
Orthopaedic bone nutOrthopaedic bone nutClass IIb
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass IIb
Elbow radius prosthesisElbow radius prosthesisClass IIb
Vertebral body prosthesisVertebral body prosthesisClass IIb
Orthopaedic cement non-antimicrobialOrthopaedic cement non-antimicrobialClass IIb
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass IIb
Metallic spinal interbody fusion cageMetallic spinal interbody fusion cageClass IIb
Bone distraction forcepsBone distraction forcepsClass IIb
Arthrodesis nail sterileArthrodesis nail sterileClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Vertebral body prosthesisVertebral body prosthesisClass IIb
Orthopaedic bone wireOrthopaedic bone wireClass IIb
Orthopaedic bone wireOrthopaedic bone wireClass IIb
Extra-gynaecological surgical mesh metalExtra-gynaecological surgical mesh metalClass IIb
Extra-gynaecological surgical mesh metalExtra-gynaecological surgical mesh metalClass IIb
Craniofacial bone screw non-bioabsorbable sterileCraniofacial bone screw non-bioabsorbable sterileClass IIb
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Orthopaedic fixation plate kit non-bioabsorbable non-antimicrobialOrthopaedic fixation plate kit non-bioabsorbable non-antimicrobialClass IIb
Inflatable bone tampInflatable bone tampClass IIb
Vertical expandable prosthetic rib systemVertical expandable prosthetic rib systemClass IIb
Implantable craniofacial bone distractorImplantable craniofacial bone distractorClass IIb
Spiral bladeSpiral bladeClass IIb
Spiral bladeSpiral bladeClass IIb
Temporary mandibular condyle prosthesisTemporary mandibular condyle prosthesisClass IIb
Temporary mandibular condyle prosthesisTemporary mandibular condyle prosthesisClass IIb
Orthodontic anchor plateOrthodontic anchor plateClass IIb
Femur nail non-sterileFemur nail non-sterileClass IIb
Tibia nail non-sterileTibia nail non-sterileClass IIb
Vertebral bone filler non-bioabsorbableVertebral bone filler non-bioabsorbableClass IIb
Flexible bone nail non-sterileFlexible bone nail non-sterileClass IIb
Lumbar interspinous decompression spacer sterileLumbar interspinous decompression spacer sterileClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable sterileClass IIb
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass IIb
Internal orthopaedic fixation system cerclage wire/cable non-sterileInternal orthopaedic fixation system cerclage wire/cable non-sterileClass IIb
Craniofacial bone screw non-bioabsorbable non-sterileCraniofacial bone screw non-bioabsorbable non-sterileClass IIb
Orthopaedic fixation plate bending insert single-useOrthopaedic fixation plate bending insert single-useClass IIb
Orthopaedic fixation plate bending insert single-useOrthopaedic fixation plate bending insert single-useClass IIb
Flexible bone nail sterileFlexible bone nail sterileClass IIb
Humerus nail non-sterileHumerus nail non-sterileClass IIb
Polymeric spinal interbody fusion cagePolymeric spinal interbody fusion cageClass IIb
Bone nail end-cap non-sterileBone nail end-cap non-sterileClass IIb
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass IIb
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIb
Orthopaedic fixation plate non-bioabsorbable non-sterileOrthopaedic fixation plate non-bioabsorbable non-sterileClass IIb
Orthopaedic bone nutOrthopaedic bone nutClass IIb
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Femur nail sterileFemur nail sterileClass IIb
Tibia nail sterileTibia nail sterileClass IIb
Bone matrix implant synthetic non-antimicrobialBone matrix implant synthetic non-antimicrobialClass III
External orthopaedic fixation frame calculation softwareExternal orthopaedic fixation frame calculation softwareClass IIb
Craniofacial fixation plate bioabsorbableCraniofacial fixation plate bioabsorbableClass III
Orthopaedic broachOrthopaedic broachClass IIa
Bone/joint surgical power tool motor electricBone/joint surgical power tool motor electricClass IIa
Orthopaedic bone staple non-adjustableOrthopaedic bone staple non-adjustableClass IIb
Surgical implant template single-useSurgical implant template single-useClass IIa
Surgical implant template reusableSurgical implant template reusableClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Orthopaedic implantation sleeve single-useOrthopaedic implantation sleeve single-useClass IIa
Orthopaedic trocar blade single-useOrthopaedic trocar blade single-useClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Surgical countersink reusableSurgical countersink reusableClass IIa
Bone nail guidewire single-useBone nail guidewire single-useClass IIa
Pneumatic surgical power tool hosePneumatic surgical power tool hoseClass IIa
Wire-driving power tool attachmentWire-driving power tool attachmentClass IIa
Surgical drill chuck keySurgical drill chuck keyClass IIa
Surgical saw blade reciprocating reusableSurgical saw blade reciprocating reusableClass IIa
Surgical air terminal unitSurgical air terminal unitClass IIa
Surgical air pipeline system filterSurgical air pipeline system filterClass IIa
Surgical power tool battery-exchange sterility coverSurgical power tool battery-exchange sterility coverClass IIa
Multi-purpose surgical power tool system rechargeable battery-poweredMulti-purpose surgical power tool system rechargeable battery-poweredClass IIa
Automatic cranial perforator reusableAutomatic cranial perforator reusableClass IIa
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Surgical retractor/retraction system blade reusableSurgical retractor/retraction system blade reusableClass IIa
Surgical saw blade sagittal reusableSurgical saw blade sagittal reusableClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass IIa
Neurophysiologic monitoring systemNeurophysiologic monitoring systemClass IIa
Surgical instrument torque limiterSurgical instrument torque limiterClass IIa
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass IIa
Self-retaining surgical retractor reusableSelf-retaining surgical retractor reusableClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing setClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Medullary canal orthopaedic reamer flexibleMedullary canal orthopaedic reamer flexibleClass IIa
Orthopaedic implantation sleeve single-useOrthopaedic implantation sleeve single-useClass IIa
Orthopaedic implant/instrument adaptor single-useOrthopaedic implant/instrument adaptor single-useClass IIa
Surgical power tool drive-shaft sealSurgical power tool drive-shaft sealClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Orthopaedic bone-fragment manipulator single-use sterileOrthopaedic bone-fragment manipulator single-use sterileClass IIa
Fibreoptic operating light systemFibreoptic operating light systemClass IIa
Surgical instrument guard single-use sterileSurgical instrument guard single-use sterileClass IIa
Surgical screwdriver single-use sterileSurgical screwdriver single-use sterileClass IIa
Bone marrow biopsy needle single-useBone marrow biopsy needle single-useClass IIa
Inflatable bone tampInflatable bone tampClass IIa
Burring power tool attachmentBurring power tool attachmentClass IIa
Drilling power tool attachment basicDrilling power tool attachment basicClass IIa
Drilling power tool attachment oscillatingDrilling power tool attachment oscillatingClass IIa
Sawing power tool attachment oscillatingSawing power tool attachment oscillatingClass IIa
Medullary canal orthopaedic reamer rigidMedullary canal orthopaedic reamer rigidClass IIa
Sawing power tool attachment sagittalSawing power tool attachment sagittalClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Trephining power tool attachmentTrephining power tool attachmentClass IIa
Surgical power tool irrigation-control deviceSurgical power tool irrigation-control deviceClass IIa
Surgical power tool system handpiece rotary pneumaticSurgical power tool system handpiece rotary pneumaticClass IIa
Multi-purpose surgical power tool system pneumaticMulti-purpose surgical power tool system pneumaticClass IIa
Bone graft harvesting filterBone graft harvesting filterClass IIa
Spinal implant trialSpinal implant trialClass IIa
Surgical implant template reusableSurgical implant template reusableClass IIa
Orthopaedic bone-fragment manipulator single-use non-sterileOrthopaedic bone-fragment manipulator single-use non-sterileClass IIa
Surgical countersink reusableSurgical countersink reusableClass IIa
Bone tap reusableBone tap reusableClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Surgical power tool system control unit line-poweredSurgical power tool system control unit line-poweredClass IIa
Surgical saw blade oscillating reusableSurgical saw blade oscillating reusableClass IIa
Orthopaedic cement preparation/delivery kitOrthopaedic cement preparation/delivery kitClass IIa
Foot-switch electricalFoot-switch electricalClass IIa
Surgical power tool hand-switchSurgical power tool hand-switchClass IIa
Bone distraction forcepsBone distraction forcepsClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Surgical power tool system handpiece rotary rechargeable battery-poweredSurgical power tool system handpiece rotary rechargeable battery-poweredClass IIa
Multi-purpose surgical power tool system line-poweredMulti-purpose surgical power tool system line-poweredClass IIa
Bone grafting cannulaBone grafting cannulaClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Surgical drill chuckSurgical drill chuckClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Bone-nailing compression screwBone-nailing compression screwClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Orthopaedic reamer guideOrthopaedic reamer guideClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical drill chuckSurgical drill chuckClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic chisel bladeOrthopaedic chisel bladeClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Bone tap reusableBone tap reusableClass I
Knee tibia prosthesis trial reusableKnee tibia prosthesis trial reusableClass I
Orthopaedic fixation plate non-bioabsorbable sterileOrthopaedic fixation plate non-bioabsorbable sterileClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Humerus nail sterileHumerus nail sterileClass IIb
Surgical implant template single-useSurgical implant template single-useClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Orthopaedic implant aiming armOrthopaedic implant aiming armClass I
Orthopaedic chisel bladeOrthopaedic chisel bladeClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Bone-nailing compression screwBone-nailing compression screwClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical instrument/endoscope cleaning utensil single-useSurgical instrument/endoscope cleaning utensil single-useClass I
Orthopaedic fixation plate non-bioabsorbable sterileOrthopaedic fixation plate non-bioabsorbable sterileClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
External orthopaedic fixation system single-useExternal orthopaedic fixation system single-useClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Surgical tamp reusableSurgical tamp reusableClass I
Fibreoptic light cableFibreoptic light cableClass I
Surgical retraction system mounting frame reusableSurgical retraction system mounting frame reusableClass I
Orthopaedic graft inserterOrthopaedic graft inserterClass I
Bone graft packing blockBone graft packing blockClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Surgical drill chuckSurgical drill chuckClass I
Automatic cranial perforator reusableAutomatic cranial perforator reusableClass IIa
Battery boxBattery boxClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Orthopaedic broachOrthopaedic broachClass IIa
Orthopaedic broachOrthopaedic broachClass IIa
Foot-switch electricalFoot-switch electricalClass IIa
Surgical power tool system control unit line-poweredSurgical power tool system control unit line-poweredClass IIa
Drilling power tool attachment oscillatingDrilling power tool attachment oscillatingClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Surgical drill chuck keySurgical drill chuck keyClass I
Surgical saw blade oscillating reusableSurgical saw blade oscillating reusableClass IIa
Surgical saw blade oscillating reusableSurgical saw blade oscillating reusableClass IIa
Surgical saw blade reciprocating reusableSurgical saw blade reciprocating reusableClass IIa
Surgical saw blade reciprocating reusableSurgical saw blade reciprocating reusableClass IIa
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass IIa
Surgical saw blade sagittal reusableSurgical saw blade sagittal reusableClass IIa
Surgical saw blade sagittal reusableSurgical saw blade sagittal reusableClass IIa
Surgical saw blade oscillating single-useSurgical saw blade oscillating single-useClass IIa
Secondary batterySecondary batteryClass IIa
Surgical power tool hand-switchSurgical power tool hand-switchClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIa
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass IIb
Surgical instrument/implant rackSurgical instrument/implant rackClass I
Pneumatic surgical power tool hosePneumatic surgical power tool hoseClass IIa
Bone/joint surgical power tool motor pneumaticBone/joint surgical power tool motor pneumaticClass IIa
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Wire holding/twisting forcepsWire holding/twisting forcepsClass I
General-purpose surgical scissors reusableGeneral-purpose surgical scissors reusableClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Craniofacial bone distractor extensionCraniofacial bone distractor extensionClass I
Craniofacial alignment rodCraniofacial alignment rodClass I
Surgical water bath systemSurgical water bath systemClass I
Surgical instrument clipSurgical instrument clipClass I
Wire holding/twisting forcepsWire holding/twisting forcepsClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
External orthopaedic fixation system reprocessed componentExternal orthopaedic fixation system reprocessed componentClass I
Pelvic C-clampPelvic C-clampClass I
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass I
Femur nail sterileFemur nail sterileClass IIb
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIb
Orthopaedic bone nutOrthopaedic bone nutClass IIb
Orthopaedic bone nutOrthopaedic bone nutClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Automatic cranial perforator reusableAutomatic cranial perforator reusableClass IIa
Surgical instrument maintenance lubricantSurgical instrument maintenance lubricantClass I
Burring power tool attachmentBurring power tool attachmentClass IIa
Wire-driving power tool attachmentWire-driving power tool attachmentClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic bur single-useOrthopaedic bur single-useClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Noninvasive device battery chargerNoninvasive device battery chargerClass I
Orthopaedic bone calliperOrthopaedic bone calliperClass I
Surgical instrument torque limiterSurgical instrument torque limiterClass IIa
Surgical power tool battery-exchange sterility coverSurgical power tool battery-exchange sterility coverClass IIa
Rechargeable battery packRechargeable battery packClass IIa
Surgical power tool maintenance adaptorSurgical power tool maintenance adaptorClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Sternal fixation deviceSternal fixation deviceClass IIb
Orthopaedic bone screw bioabsorbableOrthopaedic bone screw bioabsorbableClass III
Bone nail end-capBone nail end-capClass IIb
Surgical saw blade oscillating single-useSurgical saw blade oscillating single-useClass IIa
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Implantable craniofacial bone distractorImplantable craniofacial bone distractorClass IIb
Craniofacial bone distractor extensionCraniofacial bone distractor extensionClass IIb
Surgical power tool adaptorSurgical power tool adaptorClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Surgical power tool adaptorSurgical power tool adaptorClass I
Surgical power tool maintenance unitSurgical power tool maintenance unitClass I
Orthopaedic bur single-useOrthopaedic bur single-useClass IIa
Sternal fixation deviceSternal fixation deviceClass IIb
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
Surgical implant template reusableSurgical implant template reusableClass I
Bone tap reusableBone tap reusableClass I
Bone awl reusableBone awl reusableClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Spiral bladeSpiral bladeClass IIb
Orthopaedic trocar blade single-useOrthopaedic trocar blade single-useClass IIa
Internal orthopaedic fixation system cerclage wire/cable sterileInternal orthopaedic fixation system cerclage wire/cable sterileClass IIb
Internal orthopaedic fixation system cerclage wire/cable non-sterileInternal orthopaedic fixation system cerclage wire/cable non-sterileClass IIb
Polymeric spinal interbody fusion cagePolymeric spinal interbody fusion cage Conformity Assessment Certificate ExpiredClass III
Orthopaedic fixation plate non-bioabsorbable sterileOrthopaedic fixation plate non-bioabsorbable sterileClass IIb
Orthopaedic fixation plate non-bioabsorbable non-sterileOrthopaedic fixation plate non-bioabsorbable non-sterileClass IIb
Surgical drill chuckSurgical drill chuckClass IIa
Sawing power tool attachment sagittalSawing power tool attachment sagittalClass IIa
Sawing power tool attachment oscillatingSawing power tool attachment oscillatingClass IIa
Drilling power tool attachment basicDrilling power tool attachment basicClass IIa
Surgical power tool adaptorSurgical power tool adaptorClass IIa
Automatic cranial perforator reusableAutomatic cranial perforator reusableClass IIa
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Drilling power tool attachment oscillatingDrilling power tool attachment oscillatingClass IIa
Trephining power tool attachmentTrephining power tool attachmentClass IIa
Burring power tool attachmentBurring power tool attachmentClass IIa
Wire-driving power tool attachmentWire-driving power tool attachmentClass IIa
Sawing power tool attachment reciprocatingSawing power tool attachment reciprocatingClass IIa
Surgical irrigation/aspiration tubing setSurgical irrigation/aspiration tubing setClass IIa
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass IIa
Surgical power tool irrigation-control deviceSurgical power tool irrigation-control deviceClass IIa