Consulting Wallah › Device Explorer › Orthopaedic implants › Internal orthopaedic fixation system, plate/screw,
Device Explorer · FDA GUDID · GMDN 61689

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile

A non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of

US‑registered devices3,742in commercial distribution
Companies20labelers on GUDID
Single‑use95%of device records
Sterile0%labelled sterile
Prescription43%Rx‑only share
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Share of device records

Globus Medical, Inc.2,11256%
Zimmer Gmbh48713%
Acumed Llc40811%
Paragon 28, Inc.2346%
Conventus Orthopaedics, Inc.1344%
Laboratoires Bodycad Inc622%
Exactech, Inc.622%
Double Medical Technology Inc.451%

Top labelers

CompanyDevicesShare
Globus Medical, Inc.2,11256%
Zimmer Gmbh48713%
Acumed Llc40811%
Paragon 28, Inc.2346%
Conventus Orthopaedics, Inc.1344%
Laboratoires Bodycad Inc622%
Exactech, Inc.622%
Double Medical Technology Inc.451%
Ascension Orthopedics, Inc.391%
Zimmer, Inc.331%
Miami Device Solutions Llc311%
Sig Medical Corp.291%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

The Locking Pediatric Osteotomy Plate (LolliPOP)Distal Femoral Locking Plate Ⅱ, Combi-holesOlecranon Locking Plate Ⅱ, Combi-holesCalcaneal Locking Plate ⅡProximal Humeral Locking Plate Ⅱ, Combi-holesLateral Tibial Head Buttress Locking Plate ⅠOlecranon Locking Plates Ⅲ, Combi-holesVEGABaby Gorilla®/Gorilla® Plating SystemGorilla Plating SystemANTHEMNANCB®Cortical screwV-TEK™docPrice™

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, bone3,052
HWCScrew, fixation, bone2,661
HRSPlate, Fixation, Bone571
HWCScrew, Fixation, Bone320
HTNWASHER, BOLT NUT275
JDSNail, Fixation, Bone92

GMDN & GCC registration

  • GMDN code 61689 · non‑implantable
  • Single‑use 95% · sterile 0% · Rx‑only 43% · 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) · 1,725Outer Diameter (Millimeter) · 916Width (Millimeter) · 45Height (Millimeter) · 8Angle (degree) · 2

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

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

3,742 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile", from 20 companies. The largest labeler is Globus Medical, Inc. with 56% of records.

Which FDA product codes apply?

HRS (Plate, fixation, bone), HWC (Screw, 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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