Consulting Wallah › Device Explorer › Orthopaedic implants › Orthopaedic fixation plate, non-bioabsorbable, non
Device Explorer · FDA GUDID · GMDN 61573

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorb

US‑registered devices6,794in commercial distribution
Companies35labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Jeil Medical Corporation1,00715%
Medartis Ag78212%
Tdm Co., Ltd.73911%
Smith & Nephew, Inc.65110%
Vilex Llc4817%
Wright Medical Technology, Inc.4727%
Orthopaedic Implant Company, The3245%
Mahe Medical Gmbh2674%

Top labelers

CompanyDevicesShare
Jeil Medical Corporation1,00715%
Medartis Ag78212%
Tdm Co., Ltd.73911%
Smith & Nephew, Inc.65110%
Vilex Llc4817%
Wright Medical Technology, Inc.4727%
Orthopaedic Implant Company, The3245%
Mahe Medical Gmbh2674%
Biomet Orthopedics, Llc2544%
Paragon 28, Inc.2474%
Neoortho Produtos Ortopédicos S/A.2434%
Fusion Orthopedics, Llc2384%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

POLARSTEMDistal Femoral Locking Plate Ⅱ, Combi-holesOlecranon Locking Plate Ⅱ, Combi-holesProximal Humeral Locking Plate Ⅱ, Combi-holesLateral Tibial Head Buttress Locking Plate ⅠOlecranon Locking Plates Ⅲ, Combi-holes2.7mm LCP (TM) Plate 8 Holes3.5mm Proximal Tibia Plate 4 Holes Left3.5mm Proximal Tibia Plate 4 Holes Right4.5mm/3.5mm LCP Metaphyseal Plate3.5mm LCP Extra Articlr Distal Humerus Plate 6 HTI WIN DR-plate,long,7/5 holes,left, polyaxialTI WIN DR-plate,long,7/5 holes,right, polyaxialTI WIN DR-plate 7/3 holes,left, polyaxialTI WIN DR-plate 7/3 holes,right, polyaxialTI WIN DR-plate,short,7/3 holes,left, polyaxial

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, Bone3,524
HRSPlate, fixation, bone1,864
HRSPLATE, FIXATION, BONE1,391
HWCScrew, fixation, bone584
HWCScrew, Fixation, Bone467
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 264

GMDN & GCC registration

  • GMDN code 61573 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 97% · 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) · 787Outer Diameter (Millimeter) · 187Width (Millimeter) · 163Length (Inch) · 132Height (Millimeter) · 77Angle (degree) · 20

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

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

6,794 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, non-sterile", from 35 companies. The largest labeler is Jeil Medical Corporation 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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