Manufacturer's Devices - Stryker Leibinger GmbH & Co. KG

Address:




Botzinger Strasse 41



Freiburg

79111

Germany


Authorised Representative/ UK Responsible Person
Name: Stryker UK Ltd
Address:

Stryker House Hambridge Road



Newbury

Berkshire RG14 5AW

England United Kingdom




Code/Term Type
Implantable craniofacial bone distractorImplantable craniofacial bone distractorClass IIb
Surgical implant template single-useSurgical implant template single-useClass IIb
Hand-held intraoral dental x-ray system analogueHand-held intraoral dental x-ray system analogueClass IIb
Craniofacial alignment rodCraniofacial alignment rodClass IIb
Bone matrix implant synthetic non-antimicrobialBone matrix implant synthetic non-antimicrobialClass III
Bone matrix implant synthetic non-antimicrobialBone matrix implant synthetic non-antimicrobialClass IIb
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIb
Orbital rim prosthesisOrbital rim prosthesisClass IIb
Malar prosthesisMalar prosthesisClass IIb
Cranioplasty plate non-alterableCranioplasty plate non-alterableClass III
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Orbital sphere implantOrbital sphere implantClass IIb
Cranioplasty plate non-alterableCranioplasty plate non-alterableClass III
Ophthalmic conformerOphthalmic conformerClass IIa
Bone matrix implant synthetic non-antimicrobialBone matrix implant synthetic non-antimicrobialClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Electrosurgical cable adaptorElectrosurgical cable adaptorClass IIa
Closed-wound drainage kitClosed-wound drainage kitClass IIa
Orthopaedic bur reusableOrthopaedic bur reusableClass IIa
Robotic surgical navigation systemRobotic surgical navigation systemClass IIa
Stereotactic system application softwareStereotactic system application softwareClass IIa
Robotic surgical navigation system application softwareRobotic surgical navigation system application softwareClass IIa
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass IIa
Maxillofacial bone wire/barMaxillofacial bone wire/barClass IIa
Needle guide single-useNeedle guide single-useClass IIa
Stereotactic surgery system probe reusableStereotactic surgery system probe reusableClass IIa
Stereotactic surgery system probe single-useStereotactic surgery system probe single-useClass IIa
Multi-purpose stereotactic surgery systemMulti-purpose stereotactic surgery systemClass IIa
Orthopaedic bur single-useOrthopaedic bur single-useClass IIa
Surgical implant template reusableSurgical implant template reusableClass IIa
Imaging lesion localization marker external single-useImaging lesion localization marker external single-useClass IIa
Medical gas pipeline system emergency supplyMedical gas pipeline system emergency supplyClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIa
Electromagnetic surgical navigation device tracking systemElectromagnetic surgical navigation device tracking systemClass IIa
Orthopaedic prosthesis implantation instrument single-useOrthopaedic prosthesis implantation instrument single-useClass IIa
Intraoperative optical-tracking spatial register cranial anchorIntraoperative optical-tracking spatial register cranial anchorClass IIa
Surgical planning/navigation-enhancement systemSurgical planning/navigation-enhancement systemClass IIa
Open-surgery electrosurgical electrode monopolar single-useOpen-surgery electrosurgical electrode monopolar single-useClass IIb
Sternal fixation deviceSternal fixation deviceClass IIb
Surgical countersink single-useSurgical countersink single-useClass IIa
Craniofacial bone screw bioabsorbableCraniofacial bone screw bioabsorbableClass III
Craniofacial fixation plate bioabsorbableCraniofacial fixation plate bioabsorbableClass III
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass III
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass IIb
Polyethylene craniofacial tissue reconstructive materialPolyethylene craniofacial tissue reconstructive materialClass IIb
Bone tap single-use non-sterileBone tap single-use non-sterileClass IIa
Closed-wound drainage kitClosed-wound drainage kitClass IIa
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass IIa
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Mandibular condyle prosthesisMandibular condyle prosthesisClass IIb
External ear prosthesis implantableExternal ear prosthesis implantableClass IIb
Chin prosthesisChin prosthesisClass IIb
Medical image management systemMedical image management systemClass IIa
Dressing/utility forceps scissors-like reusableDressing/utility forceps scissors-like reusableClass I
Instrument tray reusableInstrument tray reusableClass I
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Hand-held dental retractorHand-held dental retractorClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Bone awl reusableBone awl reusableClass I
Surgical countersink reusableSurgical countersink reusableClass I
Bone tap reusableBone tap reusableClass I
Bone tap reusableBone tap reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Sternal fixation deviceSternal fixation deviceClass I
Mouth gag adjustable reusableMouth gag adjustable reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass I
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass I
External orthopaedic fixation system reusableExternal orthopaedic fixation system reusableClass I
Primary batteryPrimary batteryClass I
Robotic surgical navigation systemRobotic surgical navigation systemClass I
Robotic surgical navigation system application softwareRobotic surgical navigation system application softwareClass I
Sensor holder reusableSensor holder reusableClass I
Patient positioning sensorPatient positioning sensorClass I
Patient positioning sensorPatient positioning sensorClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass I
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass I
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass I
General surgical procedure kit medicatedGeneral surgical procedure kit medicatedClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Stereotactic surgery system probe reusableStereotactic surgery system probe reusableClass I
Stereotactic surgery system probe reusableStereotactic surgery system probe reusableClass I
Multi-purpose stereotactic surgery systemMulti-purpose stereotactic surgery systemClass I
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass I
Bone cutting forcepsBone cutting forcepsClass I
Bone cutting forcepsBone cutting forcepsClass I
Bone holding forcepsBone holding forcepsClass I
Imaging lesion localization marker external single-useImaging lesion localization marker external single-useClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Bone fixation plate pliersBone fixation plate pliersClass I
Bone fixation plate pliersBone fixation plate pliersClass I
Craniofacial alignment rodCraniofacial alignment rodClass I
Surgical water bath systemSurgical water bath systemClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Surgical power tool system handpiece rotary non-rechargeable battery-powered reusableSurgical power tool system handpiece rotary non-rechargeable battery-powered reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Electromagnetic surgical navigation device tracking systemElectromagnetic surgical navigation device tracking systemClass I
Surgical implant template single-useSurgical implant template single-useClass I
Orthopaedic prosthesis implantation instrument single-useOrthopaedic prosthesis implantation instrument single-useClass I
Intraoperative optical-tracking spatial register connectorIntraoperative optical-tracking spatial register connectorClass I
Surgical planning/navigation-enhancement systemSurgical planning/navigation-enhancement systemClass I
Optical surgical navigation device tracking systemOptical surgical navigation device tracking systemClass I
Hand-held surgical retractor reusableHand-held surgical retractor reusableClass I
Intranasal splint non-biodegradableIntranasal splint non-biodegradableClass I
Dressing/utility forceps scissors-like reusableDressing/utility forceps scissors-like reusableClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Haemodialysis fistula dressingHaemodialysis fistula dressingClass IIa
Cranioplasty plate non-alterableCranioplasty plate non-alterableClass IIb
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass IIa
Dressing/utility forceps scissors-like reusableDressing/utility forceps scissors-like reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Synthetic bone graftSynthetic bone graftClass IIb
Nasal implant synthetic polymer non-bioabsorbableNasal implant synthetic polymer non-bioabsorbableClass IIb
Craniofacial bone screw non-bioabsorbable non-sterileCraniofacial bone screw non-bioabsorbable non-sterileClass IIb
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass I
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Orthopaedic prosthesis implantation instrument reusableOrthopaedic prosthesis implantation instrument reusableClass I
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Ophthalmic conformerOphthalmic conformerClass IIa
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Stereotactic surgery system probe reusableStereotactic surgery system probe reusable Conformity Assessment Certificate ExpiredClass III
Multi-purpose stereotactic surgery systemMulti-purpose stereotactic surgery systemClass I
Craniofacial bone screw non-bioabsorbable sterileCraniofacial bone screw non-bioabsorbable sterileClass IIb