Manufacturer's Devices - Smith & Nephew Inc


150 Minuteman Road


MA 1810

United States


Authorised Representative
Name: Smith & Nephew

101 Hessle Road


Yorkshire HU3 2BN

United Kingdom

Code Name Type
StopcockClass IIb
High-pressure medical gas tubingClass IIa
Stereotactic surgery system probe reusableClass III
Scalpel single-useClass I
Tendon/ligament bone anchor non-bioabsorbableClass I
Positive-pressure intravenous line needleless valve-connectorClass I
Ligament reconstruction instrument set reusableClass I
Bone tunnel plug non-cannulatedClass I
Fluted surgical drill bit single-useClass I
Arthroscopic surgical procedure kit non-medicated single-useClass I
Suturing unit single-useClass I
Arthroscopic access cannula single-useClass I
Gastro-urological guidewire single-useClass I
Bone nail guidewire reusableClass I
General internal orthopaedic fixation system implantation kitClass I
Fluted surgical drill bit single-use non-sterileClass I
Orthopaedic bone screw non-bioabsorbable non-sterileClass I
Rigid arthroscope reusableClass I
Cannulated surgical drill bit reusableClass I
Fluted surgical drill bit reusableClass I
Orthopaedic bone screw non-bioabsorbable sterileClass I
Electrical-only medical device connection cable reusableClass I
Rigid endoscopic cannula reusableClass I
Rigid endoscopic cannula single-useClass I
Orthopaedic bone screw bioabsorbableClass I
Electrosurgical handpiece single-useClass I
Arthroscopic shaver system blade single-useClass I
Polyolefin suture multifilamentClass I
Orthopaedic bur single-useClass I
Insufflation gas conditioning system control unitClass I
Radio-frequency ablation system probe reusableClass I
Surgical drill guide obturatorClass I
Arthroscopic obturatorClass I
Rigid optical hysteroscopeClass I
Rigid optical laparoscopeClass I
Endoscope sheath reusableClass I
Endoscopes/Endoscopic Instruments And AccessoriesClass I
Surgical Instruments (Re-Usable And Non-Powered)Class I
Surgical Instrument AccessoriesClass I
Accessories For Implantable Devices (Non-Invasive)Class I
Dilators And LubricantsClass I
Surgical Procedure Packs (Includes Instruments Supplied Singularly)Class I
Endoscopes/Endoscopic Instruments And AccessoriesClass I
Orthopaedic bone staple driverClass I
Orthopaedic chiselClass I
Surgical countersink reusableClass I
Orthopaedic bone particle collector reusableClass I
Bone tap reusableClass I
Surgical drill chuckClass I
Bone curette reusableClass I
Surgical malletClass I
Orthopaedic knifeClass I
Orthopaedic joint/limb rongeurClass I
Bone fileClass I
Surgical drill guide reusableClass I
Orthopaedic implant impactorClass I
Surgical torque wrench reusableClass I
Bone hookClass I
Instrument tray reusableClass I
Surgical screwdriver reusableClass I
Surgical instrument guard reusableClass I
Bone approximation clampClass I
Bone lever/elevatorClass I
Orthopaedic implant inserter/extractor reusableClass I
Surgical gougeClass I
Bone punch reusableClass I
Traction system spreader barClass I
Bone file/rasp manualClass I
Endoscopic video imaging systemClass I
Orthopaedic broachClass I
Orthopaedic bur reusableClass I
Orthopaedic osteotomeClass I
General-purpose suction system vacuumClass I
Medical table clampClass I
Orthopaedic osteotome blade reusableClass I
Periosteal elevator reusableClass I
General-purpose surgical scissors reusableClass I
Implant handling forceps scissors-likeClass I
Surgical instrument/implant rackClass I
Orthopaedic prosthesis implantation instrument reusableClass I
Surgical saw blade sagittal single-useClass I
Drilling power tool attachment basicClass I
Surgical flat-nosed pliersClass I
Orthopaedic cement extractor manualClass I
Surgical drill chuck keyClass I
Joint prosthesis implantation kit reusableClass I
Manual orthopaedic bender reusableClass I
Sterilization/disinfection containerClass I
Orthopaedic reamer guideClass I
Bone-resection orthopaedic reamer reusableClass I
Medullary canal orthopaedic reamer rigidClass I
Orthopaedic stereotactic surgery systemClass I
Bone trephineClass I
Orthopaedic trocar blade reusableClass I
Orthopaedic cement/bone filler dispensing gunClass I
Orthopaedic fixation plate tensionerClass I
Orthopaedic implant aiming armClass I
Orthopaedic implant/trial-implant/sizer holder reusableClass I
Orthopaedic implant aiming/guiding block reusableClass I
Surgical instrument handle non-torque-limitingClass I
Orthopaedic implantation sleeve reusableClass I
Orthopaedic implant/instrument adaptor reusableClass I
Bone awlClass I
Orthopaedic implant/instrument depth limiterClass I
External orthopaedic fixation system single-use non-sterileClass I
External orthopaedic fixation system single-use sterileClass I
Orthopaedic bone-fragment manipulator reusableClass I
Orthopaedic surgical distractor internalClass I
Osteochondral matrix implantClass I
Orthopaedic fixation plate non-bioabsorbable sterileClass I
Fibreoptic light cableClass I
Suturing unit reusableClass I
Orthopaedic implant calibration pinClass I
Infusion controller line-poweredClass I
Arthroscopic irrigation/insufflation systemClass I
ENT elevatorClass I
Endoscopic device remote controlClass I