Manufacturer's Devices - Paragon 28 Inc

Address:




14445 Grasslands Dr. Englewood



Douglas

Colorado 80112

United States


Authorised Representative/ UK Responsible Person
Name: Ortho Consulting Group Ltd
Address:

Building 81 Greenham Business Park



Newbury

Berkshire RG19 6HW

England United Kingdom




Code/Term Type
Metallic osteotomy fusion cage non-customizedMetallic osteotomy fusion cage non-customizedClass IIb
Cannulated surgical drill bit single-use sterileCannulated surgical drill bit single-use sterileClass IIa
Surgical screwdriver single-use sterileSurgical screwdriver single-use sterileClass IIa
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass IIa
Orthopaedic surgical procedure kit non-medicated reusableOrthopaedic surgical procedure kit non-medicated reusableClass IIa
Bone trephineBone trephineClass IIa
Surgical saw blade sagittal single-useSurgical saw blade sagittal single-useClass IIa
Visual incentive training deviceVisual incentive training deviceClass IIa
Cannulated surgical drill bit reusableCannulated surgical drill bit reusableClass IIa
Orthopaedic bone screw non-bioabsorbable non-sterileOrthopaedic bone screw non-bioabsorbable non-sterileClass IIb
Orthopaedic bone washer non-sterileOrthopaedic bone washer non-sterileClass IIb
Orthopaedic bone washer sterileOrthopaedic bone washer sterileClass IIb
Interphalangeal joint arthrodesis implantInterphalangeal joint arthrodesis implantClass IIb
Orthopaedic bone wireOrthopaedic bone wireClass IIb
Orthopaedic bone staple non-adjustableOrthopaedic bone staple non-adjustableClass IIb
Internal orthopaedic fixation system plate/screw non-bioabsorbable sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable sterileClass IIb
Orthopaedic bone screw non-bioabsorbable sterileOrthopaedic bone screw non-bioabsorbable sterileClass IIb
Orthopaedic chiselOrthopaedic chiselClass I
Dressing/utility forceps scissors-like reusableDressing/utility forceps scissors-like reusableClass I
Orthopaedic osteotomeOrthopaedic osteotomeClass I
Sterilization/disinfection container reusableSterilization/disinfection container reusableClass I
Bone tap reusableBone tap reusableClass I
Bone curette reusableBone curette reusableClass I
Surgical malletSurgical malletClass I
Surgical depth gauge reusableSurgical depth gauge reusableClass I
Bone hookBone hookClass I
Bone approximation clampBone approximation clampClass I
Bone file/rasp manual reusableBone file/rasp manual reusableClass I
Periosteal elevator reusablePeriosteal elevator reusableClass I
Drilling power tool attachment basicDrilling power tool attachment basicClass I
Bone distraction forcepsBone distraction forcepsClass I
Medical ruler reusableMedical ruler reusableClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Surgical instrument torque limiterSurgical instrument torque limiterClass I
Orthopaedic surgical distractor internalOrthopaedic surgical distractor internalClass I
Surgical implant handling forcepsSurgical implant handling forcepsClass I
Orthopaedic implant aiming/guiding block attachment toolOrthopaedic implant aiming/guiding block attachment toolClass I
Osteotomy guide reusableOsteotomy guide reusableClass I
Orthopaedic graft inserterOrthopaedic graft inserterClass I
Surgical tamp reusableSurgical tamp reusableClass I
Surgical instrument/endoscope cleaning utensil reusableSurgical instrument/endoscope cleaning utensil reusableClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Orthopaedic bone wireOrthopaedic bone wireClass I
Orthopaedic implant aiming/guiding block reusableOrthopaedic implant aiming/guiding block reusableClass I
Orthopaedic fixation implant alignment toolOrthopaedic fixation implant alignment toolClass I
Orthopaedic implantation sleeve reusableOrthopaedic implantation sleeve reusableClass I
Cartilage knifeCartilage knifeClass I
Bone holding forcepsBone holding forcepsClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
General internal orthopaedic fixation system implantation kitGeneral internal orthopaedic fixation system implantation kitClass I
Orthopaedic implant inserter/extractor reusableOrthopaedic implant inserter/extractor reusableClass I
Osteotomy compression/distraction instrumentOsteotomy compression/distraction instrumentClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass IIa
Surgical countersink reusableSurgical countersink reusableClass IIa
Internal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileInternal orthopaedic fixation system plate/screw non-bioabsorbable non-sterileClass IIb
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Orthopaedic bone wireOrthopaedic bone wireClass IIa
Fluted surgical drill bit single-useFluted surgical drill bit single-useClass IIa