Consulting Wallah › Device Explorer › Other devices › Femur nail, non-sterile
Device Explorer · FDA GUDID · GMDN 56643

Femur nail, non-sterile

A non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the

US‑registered devices636in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Syntec Scientific Corporation16726%
Flow-Fx13621%
Biomet Orthopedics, Llc13020%
Orthopaedic Implant Company, The11218%
Cg Medtech Co.,Ltd.6610%
Advanced Orthopaedic Solutions, Inc.234%
Orthofix Srl10%
Seaspine Orthopedics Corporation10%

Top labelers

CompanyDevicesShare
Syntec Scientific Corporation16726%
Flow-Fx13621%
Biomet Orthopedics, Llc13020%
Orthopaedic Implant Company, The11218%
Cg Medtech Co.,Ltd.6610%
Advanced Orthopaedic Solutions, Inc.234%
Orthofix Srl10%
Seaspine Orthopedics Corporation10%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Syntec Femoral Nail SystemA.R.T.™FEMORAL NAILACE ™TROCHANTERIC NAILVERSANAIL®TROCH ENTRY NAIL LEFTVERSANAIL®TROCH ENTRY NAIL RIGHTVERSANAIL®UNIVERSAL FEMORAL NAILAIM™SUPRACONDYLAR NAILAIM™FEMORAL NAILAIM®FEMORAL NAILAOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 30cm xAOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 48cm x AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 45cm x AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 42cm x AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 39cm x AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 36cm x AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 30cm x

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

FDA product codes

CodeNameDevices
HSBRod, Fixation, Intramedullary And Accessories441
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES196
JDSNAIL, FIXATION, BONE54
HTNWASHER, BOLT NUT14
LXTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 14
HWCScrew, fixation, bone14

GMDN & GCC registration

  • GMDN code 56643 · non‑implantable
  • Single‑use 100% · sterile 0% · 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) · 113Outer Diameter (Millimeter) · 113Angle (degree) · 28

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

How many femur nail, non-sterile products are registered in the US?

636 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Femur nail, non-sterile", from 8 companies. The largest labeler is Syntec Scientific Corporation with 26% of records.

Which FDA product codes apply?

HSB (Rod, Fixation, Intramedullary And Accessories), HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES), JDS (NAIL, FIXATION, BONE), HTN (WASHER, BOLT NUT)

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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