Manufacturer's Devices - Orthofix Inc.

Address:




3451 Plano Parkway



Lewisville

Texas 75056

United States


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Metallic spinal interbody fusion cageMetallic spinal interbody fusion cageClass IIb
Bone-screw internal spinal fixation system sterileBone-screw internal spinal fixation system sterileClass IIb
Spinal fixation plate non-bioabsorbableSpinal fixation plate non-bioabsorbableClass IIb
Sacroiliac joint transarticular fixation/arthrodesis implant uncoatedSacroiliac joint transarticular fixation/arthrodesis implant uncoatedClass IIb
Bone-screw internal spinal fixation system non-sterileBone-screw internal spinal fixation system non-sterileClass IIb
Internal spinal fixation procedure kit reusableInternal spinal fixation procedure kit reusableClass IIa
Sacroiliac joint transarticular fixation/arthrodesis implant uncoated non-sterileSacroiliac joint transarticular fixation/arthrodesis implant uncoated non-sterileClass IIa
Instrument tray reusableInstrument tray reusableClass IIa
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass IIb
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass IIb
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I
Growth-correction orthopaedic fixation plate kitGrowth-correction orthopaedic fixation plate kitClass I