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Device Explorer · FDA GUDID · GMDN 38152

Tibia intramedullary nail

A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the tibia to immobilize the ends of a fractured bone in position to promote healing; it is not dedicated to extension beyond the joint to an adjacent bone (i.

US‑registered devices3,104in commercial distribution
Companies18labelers on GUDID
Single‑use100%of device records
Sterile77%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Orthopediatrics Corp.84527%
Smith & Nephew, Inc.35111%
Zimmer, Inc.31810%
Biomet Orthopedics, Llc29810%
Nuvasive Specialized Orthopedics, Inc.2608%
Synthes Gmbh2468%
Stryker Gmbh2317%
Orthofix Srl1595%

Top labelers

CompanyDevicesShare
Orthopediatrics Corp.84527%
Smith & Nephew, Inc.35111%
Zimmer, Inc.31810%
Biomet Orthopedics, Llc29810%
Nuvasive Specialized Orthopedics, Inc.2608%
Synthes Gmbh2468%
Stryker Gmbh2317%
Orthofix Srl1595%
Orthoxel Designated Activity Company863%
Double Medical Technology Inc.803%
Tdm Co., Ltd.722%
Auxein Medical Private Limited472%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2 ALPHAT2FASSIER-DUVAL TELESCOPIC IM SYSTEMPiccolo Composite Nailing SystemUniversal Tibial Nail, SolidUniversal Tibial Nail, CannulatedUniversal Tibial Nail II, Cannulated4.5mm Locking Screw for Tibial NailApexTRIWAYTRIGENTRIGEN META-NAILTrigenNatural Nail®M/DN®PHOENIX TIBIAL NAIL SYSTEM

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 ACCESSORIES1,915
HSBRod, Fixation, Intramedullary And Accessories858
JDSNAIL, FIXATION, BONE739
HWCScrew, fixation, bone286
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 82
HRSPLATE, FIXATION, BONE82

GMDN & GCC registration

  • GMDN code 38152 · implantable
  • Single‑use 100% · sterile 77% · 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) · 715Outer Diameter (Millimeter) · 408Length (Centimeter) · 204Outer Diameter (Micrometer) · 1Lumen/Inner Diameter (Millimeter) · 1

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

How many tibia intramedullary nail products are registered in the US?

3,104 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Tibia intramedullary nail", from 18 companies. The largest labeler is Orthopediatrics Corp. with 27% of records.

Which FDA product codes apply?

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