Manufacturer's Devices - Depuy Mitek Inc.

Address:




Depuy Mitek Inc. 325 Paramount Drive



Raynham

MA 02767

United States


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
Arthroscopic suturing unitArthroscopic suturing unitClass I
Bone curette reusableBone curette reusableClass I
Orthopaedic knifeOrthopaedic knifeClass I
Orthopaedic bone pin non-bioabsorbableOrthopaedic bone pin non-bioabsorbableClass I
Surgical drill guide obturatorSurgical drill guide obturatorClass I
Tendon/ligament tunnellerTendon/ligament tunnellerClass I
Surgical suction system collection container single-useSurgical suction system collection container single-useClass I
Surgical gougeSurgical gougeClass I
Tendon stripperTendon stripperClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Orthopaedic bur reusableOrthopaedic bur reusableClass I
Foot-switch electricalFoot-switch electricalClass I
Suturing unit reusableSuturing unit reusableClass I
Electromechanical device/system transport trolleyElectromechanical device/system transport trolleyClass I
Orthopaedic graft inserterOrthopaedic graft inserterClass I
Ligament graft sizer noninvasiveLigament graft sizer noninvasiveClass I
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass I
Suture knot pusher reusableSuture knot pusher reusableClass I
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Orthopaedic implant calibration pinOrthopaedic implant calibration pinClass I
Tendon/ligament graft preparation stationTendon/ligament graft preparation stationClass I
Orthopaedic instrument extractorOrthopaedic instrument extractorClass I
Polyester suture bioabsorbable monofilament non-antimicrobialPolyester suture bioabsorbable monofilament non-antimicrobialClass III
Orthopaedic bone screw bioabsorbableOrthopaedic bone screw bioabsorbableClass III
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIb
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Endoscope sheath reusableEndoscope sheath reusableClass IIa
Electrosurgical system generatorElectrosurgical system generatorClass IIb
Suturing unit reusableSuturing unit reusableClass IIa
Suturing unit reusableSuturing unit reusableClass IIa
Assistive drinking strawAssistive drinking strawClass IIa
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Arthroscopic surgical procedure kit non-medicated single-useArthroscopic surgical procedure kit non-medicated single-useClass IIa
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass IIa
Surgical irrigation tubing set single-useSurgical irrigation tubing set single-useClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass IIa
Scalpel single-useScalpel single-useClass IIa
Suturing unit single-useSuturing unit single-useClass IIa
Open-surgery dissectorOpen-surgery dissectorClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Bone trephineBone trephineClass I
Bone awl reusableBone awl reusableClass I
Suture cutter reusableSuture cutter reusableClass I
Bone tap reusableBone tap reusableClass I
Arthroscopic access cannula single-useArthroscopic access cannula single-useClass IIa
Arthroscopic shaver system blade single-useArthroscopic shaver system blade single-useClass IIa
Instrument tray reusableInstrument tray reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Surgical malletSurgical malletClass I
Endoscopic surgical probeEndoscopic surgical probeClass I
Orthopaedic trocar blade reusableOrthopaedic trocar blade reusableClass I
Bone nail guidewire reusableBone nail guidewire reusableClass I
Orthopaedic graft tensioner reusableOrthopaedic graft tensioner reusableClass I
Manual surgical rotary handpiece reusableManual surgical rotary handpiece reusableClass I
Rigid endoscope obturatorRigid endoscope obturatorClass I
Endoscopic video image processing unitEndoscopic video image processing unitClass I
Ligament reconstruction instrument set reusableLigament reconstruction instrument set reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Endoscope video cameraEndoscope video cameraClass I
Endoscope video cameraEndoscope video cameraClass I
Arthroscopic shaver system electrically-poweredArthroscopic shaver system electrically-poweredClass IIa
Arthroscopic irrigation/insufflation systemArthroscopic irrigation/insufflation systemClass IIa
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass IIa
Endoscopic electrosurgical electrode bipolar single-useEndoscopic electrosurgical electrode bipolar single-useClass IIb
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Orthopaedic instrument surgical connectorOrthopaedic instrument surgical connectorClass I
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass III
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass III