Manufacturer's Devices - K2M Group Holdings Inc

Address:




600 Hope Parkway SE



Leesburg

Virginia 20175

United States


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

Stryker House Hambridge Road



Newbury

Berkshire RG14 5AW

England United Kingdom




Code/Term Type
Instrument tray reusableInstrument tray reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Surgical retractor/retraction system blade reusableSurgical retractor/retraction system blade reusableClass I
Orthopaedic implant-instrument extension adaptor reusableOrthopaedic implant-instrument extension adaptor reusableClass I
Bone awl reusableBone awl reusableClass I
Manual surgical rotary handpiece reusableManual surgical rotary handpiece reusableClass I
Internal spinal fixation procedure kit single-useInternal spinal fixation procedure kit single-useClass I
Bone curette reusableBone curette reusableClass I
Orthopaedic prosthesis implantation positioning instrument reusableOrthopaedic prosthesis implantation positioning instrument reusableClass I
Surgical retraction system mounting frame reusableSurgical retraction system mounting frame reusableClass I
Lumbar interspinous decompression instrument set reusableLumbar interspinous decompression instrument set reusableClass I
Self-retaining surgical retractor reusableSelf-retaining surgical retractor reusableClass I
Nerve/vessel retractorNerve/vessel retractorClass I
Orthopaedic instrument extractorOrthopaedic instrument extractorClass I
General-purpose calliper metallicGeneral-purpose calliper metallicClass I
Surgical instrument handle torque-limitingSurgical instrument handle torque-limitingClass I
Orthopaedic implant/instrument assembling deviceOrthopaedic implant/instrument assembling deviceClass I
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass I
Vertebral body prosthesisVertebral body prosthesisClass I
Cervical total intervertebral disc prosthesis modularCervical total intervertebral disc prosthesis modularClass I
Polymeric spinal interbody fusion cagePolymeric spinal interbody fusion cageClass I
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass I
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIa
Abdominal/ENT/orthopaedic surgical probe reusableAbdominal/ENT/orthopaedic surgical probe reusableClass IIa
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass IIa
Bone tap reusableBone tap reusableClass IIa
Surgical instrument guard reusableSurgical instrument guard reusableClass IIa
Surgical drill guide reusableSurgical drill guide reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass IIb