Manufacturer's Devices - Medtronic Sofamor Danek Inc.

Address:




1800 Pyramid Place



Memphis

TN TN 38132

United States


Authorised Representative/ UK Responsible Person
Name: Medtronic Limited
Address:

Building 9 Croxley Park



Watford

Herts WD18 8WW

England United Kingdom




Code/Term Type
Bone matrix implant synthetic non-antimicrobialBone matrix implant synthetic non-antimicrobialClass III
Vertebral body prosthesisVertebral body prosthesisClass IIb
Vertebral body prosthesisVertebral body prosthesisClass IIb
Percutaneous radio-frequency ablation system generatorPercutaneous radio-frequency ablation system generatorClass IIb
Orthopaedic cement non-antimicrobialOrthopaedic cement non-antimicrobialClass IIb
Spinal bone screw non-bioabsorbableSpinal bone screw non-bioabsorbableClass IIb
Spinal bone screw non-bioabsorbableSpinal bone screw non-bioabsorbableClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIb
Spinal fixation plate non-bioabsorbableSpinal fixation plate non-bioabsorbableClass IIb
Spinal fixation plate non-bioabsorbableSpinal fixation plate non-bioabsorbableClass IIb
Cervical total intervertebral disc prosthesis modularCervical total intervertebral disc prosthesis modularClass IIb
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
Radio-frequency ablation systemRadio-frequency ablation systemClass IIb
Spinal dynamic-stabilization systemSpinal dynamic-stabilization systemClass IIb
Spinal dynamic-stabilization systemSpinal dynamic-stabilization systemClass IIb
Sacroiliac joint transarticular fixation/arthrodesis implant uncoated sterileSacroiliac joint transarticular fixation/arthrodesis implant uncoated sterileClass IIb
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIb
Polymeric spinal interbody fusion cagePolymeric spinal interbody fusion cageClass IIb
Polymeric spinal interbody fusion cagePolymeric spinal interbody fusion cageClass IIb
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass IIb
Metallic spinal interbody fusion cageMetallic spinal interbody fusion cageClass IIb
Metallic spinal interbody fusion cageMetallic spinal interbody fusion cageClass IIb
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIb
Bone cutterBone cutterClass IIa
Open-surgery dissectorOpen-surgery dissectorClass IIa
Catheter/overtube balloon inflator single-useCatheter/overtube balloon inflator single-useClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Orthopaedic implant driverOrthopaedic implant driverClass IIa
Orthopaedic implant driverOrthopaedic implant driverClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIa
Orthopaedic broachOrthopaedic broachClass IIa
Screwing power tool attachmentScrewing power tool attachmentClass IIa
Intravascular heating/cooling system catheterIntravascular heating/cooling system catheterClass IIa
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
Vertebral bone biopsy procedure kit single-useVertebral bone biopsy procedure kit single-useClass IIa
Orthopaedic counter-torque/rod-pushing instrumentOrthopaedic counter-torque/rod-pushing instrumentClass IIa
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass IIa
Radio-frequency ablation systemRadio-frequency ablation systemClass IIa
Radio-frequency ablation systemRadio-frequency ablation systemClass IIa
Radio-frequency ablation systemRadio-frequency ablation systemClass IIa
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass IIa
Spinal endoscopic-access systemSpinal endoscopic-access systemClass IIa
Spinal endoscopic-access systemSpinal endoscopic-access systemClass IIa
Nerve-locating systemNerve-locating systemClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Neurosurgical curette single-useNeurosurgical curette single-useClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIa
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass IIa
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Bone tap reusableBone tap reusableClass IIa
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Self-retaining surgical retractor reusableSelf-retaining surgical retractor reusableClass IIa
Spinal implant trialSpinal implant trialClass IIa
Surgical support tape non-bioabsorbableSurgical support tape non-bioabsorbableClass IIb
Catheter/overtube balloon inflator single-useCatheter/overtube balloon inflator single-useClass IIa
Orthopaedic cement dispenserOrthopaedic cement dispenserClass IIa
Bone access channel kitBone access channel kitClass IIa
Bone access cannulaBone access cannulaClass IIa
Bone access cannulaBone access cannulaClass IIa
Inflatable bone tampInflatable bone tampClass IIa
Open-surgery dissectorOpen-surgery dissectorClass I
Bone cutterBone cutterClass I
Instrument tray reusableInstrument tray reusableClass I
Bone trephineBone trephineClass I
Bone tap reusableBone tap reusableClass I
General-purpose calliper metallicGeneral-purpose calliper metallicClass I
Surgical malletSurgical malletClass I
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Medical device integration rackMedical device integration rackClass I
Orthopaedic cement dispenserOrthopaedic cement dispenserClass I
Orthopaedic cement dispenserOrthopaedic cement dispenserClass I
Metallic spinal interbody fusion cageMetallic spinal interbody fusion cageClass I
Screwing power tool attachmentScrewing power tool attachmentClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Internal spinal fixation system cable crimperInternal spinal fixation system cable crimperClass I
Internal spinal fixation system cable cutterInternal spinal fixation system cable cutterClass I
Surgical implant template reusableSurgical implant template reusableClass I
Orthopaedic counter-torque/rod-pushing instrumentOrthopaedic counter-torque/rod-pushing instrumentClass I
Surgical screwdriver single-use non-sterileSurgical screwdriver single-use non-sterileClass I
Orthopaedic cement/bone filler dispensing gunOrthopaedic cement/bone filler dispensing gunClass I
Bone graft packing blockBone graft packing blockClass I
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass I
Manual orthopaedic cement mixer single-useManual orthopaedic cement mixer single-useClass I
Orthopaedic chiselOrthopaedic chiselClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Bone awl reusableBone awl reusableClass I
Bone curette reusableBone curette reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Spinal endoscopic-access systemSpinal endoscopic-access systemClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Orthopaedic joint/limb rongeurOrthopaedic joint/limb rongeurClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Orthopaedic bone screw starter/notcherOrthopaedic bone screw starter/notcherClass I
Orthopaedic implant driverOrthopaedic implant driverClass I
Surgical torque wrench reusableSurgical torque wrench reusableClass I
Surgical tamp reusableSurgical tamp reusableClass I
Surgical instrument guard reusableSurgical instrument guard reusableClass I
Bone lever/elevator reusableBone lever/elevator reusableClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Endoscope camera adaptorEndoscope camera adaptorClass I
Orthopaedic osteotome blade reusableOrthopaedic osteotome blade reusableClass I
Surgical vice gripSurgical vice gripClass I
Surgical/emergency suction cannula non-illuminating reusableSurgical/emergency suction cannula non-illuminating reusableClass I
General-purpose surgical spatulaGeneral-purpose surgical spatulaClass I
Bone distraction forcepsBone distraction forcepsClass I
Multi-purpose surgical power tool system line-poweredMulti-purpose surgical power tool system line-poweredClass I
Spinal implant trialSpinal implant trialClass I
Internal spinal fixation system cable crimp sterileInternal spinal fixation system cable crimp sterileClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Orthopaedic graft inserterOrthopaedic graft inserterClass I
Medical equipment handle cover reusableMedical equipment handle cover reusableClass I
Surgical retraction system reusableSurgical retraction system reusableClass I
Self-retaining surgical retractor reusableSelf-retaining surgical retractor reusableClass I
Orthopaedic stereotactic surgery systemOrthopaedic stereotactic surgery systemClass I
Orthopaedic x-ray rulerOrthopaedic x-ray rulerClass I
Bone nail guidewire reusableBone nail guidewire reusableClass I
Surgical retractor/retraction system blade reusableSurgical retractor/retraction system blade reusableClass I
Neurosurgical curette single-useNeurosurgical curette single-useClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Leukocyte separation kitLeukocyte separation kitClass I
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass I
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass I
Orthopaedic implantation hammering attachmentOrthopaedic implantation hammering attachmentClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Surgical instrument torque limiterSurgical instrument torque limiterClass I
Orthopaedic feelerOrthopaedic feelerClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Bone graft funnelBone graft funnelClass I
Electromagnetic surgical navigation device tracking systemElectromagnetic surgical navigation device tracking systemClass I
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass I
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Orthopaedic rod reducerOrthopaedic rod reducerClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass I
Orthopaedic bone staple non-adjustableOrthopaedic bone staple non-adjustableClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass I
Internal spinal fixation system cable tensionerInternal spinal fixation system cable tensionerClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Bone matrix implant compositeBone matrix implant compositeClass III
Instrument tray reusableInstrument tray reusableClass I