Consulting Wallah › Device Explorer › Other devices › Tibia nail, non-sterile
Device Explorer · FDA GUDID · GMDN 56645

Tibia nail, non-sterile

A non-sterile rod made of metal or other material which, when inserted into the intramedullary canal of the tibia, 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 devices269in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

Cg Medtech Co.,Ltd.7528%
Biomet Orthopedics, Llc7126%
Orthopaedic Implant Company, The4617%
Vilex Llc4216%
Orthofix Srl207%
I.T.S. Gmbh104%
Renovo Life Llc31%
Smith & Nephew, Inc.10%

Top labelers

CompanyDevicesShare
Cg Medtech Co.,Ltd.7528%
Biomet Orthopedics, Llc7126%
Orthopaedic Implant Company, The4617%
Vilex Llc4216%
Orthofix Srl207%
I.T.S. Gmbh104%
Renovo Life Llc31%
Smith & Nephew, Inc.10%
Advanced Orthopaedic Solutions, Inc.10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AIM™DYNAMIC TIBIAL NAILTIBIAL NAILTRIGENTibial Nail 11mm x 40.5cmFUZEStainless Steel Tibial Nailing SystemRENOVOLIFE LLCOIC Intramedullary Nail SystemCannulated Tibia NailDyna Locking IM Nail

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 ACCESSORIES146
HSBRod, Fixation, Intramedullary And Accessories122
JDSNAIL, FIXATION, BONE1

GMDN & GCC registration

  • GMDN code 56645 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 99% · 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) · 46Outer Diameter (Millimeter) · 46

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

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

269 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tibia nail, non-sterile", from 9 companies. The largest labeler is Cg Medtech Co.,Ltd. with 28% of records.

Which FDA product codes apply?

HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES), HSB (Rod, Fixation, Intramedullary And Accessories), JDS (NAIL, 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.

How do I get quotes?

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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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