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Device Explorer · FDA GUDID · GMDN 46647

Orthopaedic fixation plate, non-bioabsorbable

A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typica

US‑registered devices34,224in commercial distribution
Companies100labelers on GUDID
Single‑use98%of device records
Sterile39%labelled sterile
Prescription95%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Synthes Gmbh5,30015%
Stryker Gmbh3,1719%
Smith & Nephew, Inc.2,6358%
Gm Dos Reis Industria E Comercio Ltda1,6755%
Arthrex, Inc.1,6025%
Orthopediatrics Corp.1,4304%
Biomet Orthopedics, Llc1,3524%
Zimmer, Inc.1,2064%

Top labelers

CompanyDevicesShare
Synthes Gmbh5,30015%
Stryker Gmbh3,1719%
Smith & Nephew, Inc.2,6358%
Gm Dos Reis Industria E Comercio Ltda1,6755%
Arthrex, Inc.1,6025%
Orthopediatrics Corp.1,4304%
Biomet Orthopedics, Llc1,3524%
Zimmer, Inc.1,2064%
Acumed Llc1,1453%
Jeil Medical Corporation9773%
Double Medical Technology Inc.9083%
Newclip Technics7882%

Company = labeler of record on GUDID. 100 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PANGEAT2, PANGEANAVARIAXPROAxSOS 3CABLEFIXAXSOSANCHORAGEEPI-UNIONOMEGADall-MilesVariAxPELVIS IIPROFYLEMATTA

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

FDA product codes

CodeNameDevices
HRSPlate, fixation, bone11,611
HRSPlate, Fixation, Bone10,857
HRSPLATE, FIXATION, BONE9,804
HWCScrew, fixation, bone7,002
HWCScrew, Fixation, Bone3,685
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 2,436

GMDN & GCC registration

  • GMDN code 46647 · implantable
  • Single‑use 98% · sterile 39% · Rx‑only 95% · 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) · 5,950Width (Millimeter) · 1,185Angle (degree) · 417Outer Diameter (Millimeter) · 342Height (Millimeter) · 206Length (Inch) · 74

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

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

34,224 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic fixation plate, non-bioabsorbable", from 100 companies. The largest labeler is Synthes Gmbh with 15% of records.

Which FDA product codes apply?

HRS (Plate, fixation, bone), 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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