Manufacturer's Devices - Extremity Medical LLC

Address:




Extremity Medical LLC Blue Slate LLC

3000 Interpace Parkway Ste 40

Parsippany NJ

07054

United States


Authorised Representative/ UK Responsible Person
Name: Templar Regulatory Consulting Limited
Address:

Niall House Unit 4 24-26 Boulton Road

Stevenage

Stevenage

Hertfordshire SG14QX

England United Kingdom




Code/Term Type
Total wrist carpal articulation prosthesisTotal wrist carpal articulation prosthesisClass IIb
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Orthopaedic fixation plate non-bioabsorbable non-sterileOrthopaedic fixation plate non-bioabsorbable non-sterileClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Cannulated surgical drill bit single-use non-sterileCannulated surgical drill bit single-use non-sterileClass IIa
Bone file/rasp reciprocating single-useBone file/rasp reciprocating single-useClass IIa
Orthopaedic surgical procedure kit non-medicated single-useOrthopaedic surgical procedure kit non-medicated single-useClass IIa
Orthopaedic chiselOrthopaedic chiselClass I
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass I
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Bone trephineBone trephineClass I
Bone awl reusableBone awl reusableClass I
Surgical malletSurgical malletClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Orthopaedic bone wireOrthopaedic bone wireClass I
Dressing/utility forceps tweezers-like reusableDressing/utility forceps tweezers-like reusableClass I
Surgical implant template reusableSurgical implant template reusableClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass I
Surgical implant template single-useSurgical implant template single-useClass I
Guidewire holderGuidewire holderClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Surgical countersink reusableSurgical countersink reusableClass I
Orthopaedic implant impactorOrthopaedic implant impactorClass I
Surgical drill guide reusableSurgical drill guide reusableClass I
Orthopaedic implant/instrument adaptor reusableOrthopaedic implant/instrument adaptor reusableClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Surgical implant/trial-implant/sizer holder reusableSurgical implant/trial-implant/sizer holder reusableClass I
Bone-resection orthopaedic reamer reusableBone-resection orthopaedic reamer reusableClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass IIa
Bone nail guidewire reusableBone nail guidewire reusableClass I