Consulting Wallah › Device Explorer › Orthopaedic implants › Orthopaedic fixation plate kit, non-bioabsorbable,
Device Explorer · FDA GUDID · GMDN 46649

Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial

A collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The components are made of a material that is not

US‑registered devices58in commercial distribution
Companies6labelers on GUDID
Single‑use88%of device records
Sterile55%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Biomet Orthopedics, Llc1933%
Orthofix Srl1526%
Osteomed Llc1017%
Wenzel Spine, Inc.712%
Wright Medical Technology, Inc.610%
Alphatec Spine, Inc.12%

Top labelers

CompanyDevicesShare
Biomet Orthopedics, Llc1933%
Orthofix Srl1526%
Osteomed Llc1017%
Wenzel Spine, Inc.712%
Wright Medical Technology, Inc.610%
Alphatec Spine, Inc.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PROstep MISPROstep™ MIS BunionetteRayhack™Rayhack™ CustomDVR® CROSSLOCKPLATE, WIDE LEFT WITH SMOOTH PEGSDVR WRISTULNA PLATE, BILATERALDVR WRISTDORSAL PLATE, STANDARD ANATOMY LEFTDVR WRISTDORSAL PLATE, STANDARD ANATOMY RIGHTDVR WRISTRADIAL STYLOID PLATE, WIDE ANATOMY LEFTDVR WRISTRADIAL STYLOID PLATE, STANDARD ANATOMY DVR WRISTRADIAL STYLOID PLATE, STANDARD ANATOMY DVR WRISTRADIAL STYLOID PLATE, WIDE ANATOMY RIGHDVR WRISTDORSAL PLATE, WIDE ANATOMY LEFTDVR WRISTDORSAL PLATE, WIDE ANATOMY RIGHTDVR® CROSSLOCKPLATE, WIDE RIGHT WITH SMOOTH PEGSDVR® CROSSLOCKDISTAL VOLAR RADIUS PLATE NARROW L

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
MAXIntervertebral fusion device with bone graft, lumbar231
HRSPLATE, FIXATION, BONE14
HRSPlate, Fixation, Bone13
HWCScrew, fixation, bone12
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL11
OBTPlate, Bone, Growth Control, Pediatric, Epiphysiodesis8

GMDN & GCC registration

  • GMDN code 46649 · non‑implantable
  • Single‑use 88% · sterile 55% · Rx‑only 100% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 246Height (Millimeter) · 13Outer Diameter (Millimeter) · 2Width (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial products are registered in the US?

58 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial", from 6 companies. The largest labeler is Biomet Orthopedics, Llc with 33% of records.

Which FDA product codes apply?

MAX (Intervertebral fusion device with bone graft, lumbar), HRS (PLATE, FIXATION, BONE), HRS (Plate, Fixation, Bone), HWC (Screw, fixation, bone)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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