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Device Explorer · FDA GUDID · GMDN 38153

Humerus intramedullary nail

A rigid rod made of metal or other material intended to be implanted into the intramedullary canal of the humerus to immobilize the ends of a fractured bone in position to promote healing; it may also be used to support the bone in the presence of a pathologic

US‑registered devices809in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile95%labelled sterile
Prescription86%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Stryker Gmbh18723%
Fournitures Hospitalieres Industrie10913%
Zimmer Gmbh9512%
Synthes Gmbh8911%
Zimmer, Inc.729%
Biomet Orthopedics, Llc719%
Orthopedic Designs North America, Inc.476%
Smith & Nephew, Inc.415%

Top labelers

CompanyDevicesShare
Stryker Gmbh18723%
Fournitures Hospitalieres Industrie10913%
Zimmer Gmbh9512%
Synthes Gmbh8911%
Zimmer, Inc.729%
Biomet Orthopedics, Llc719%
Orthopedic Designs North America, Inc.476%
Smith & Nephew, Inc.415%
Carbofix Orthopedics Ltd213%
Tdm Co., Ltd.202%
Auxein Medical Private Limited192%
Citieffe Srl152%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2Piccolo Composite Nailing SystemFixion Nailing SystemTELEGRAPH® EVOLUTION Humeral Nailing SystemTELEGRAPH®TRIGENAffixus® Natural Nail®M/DN®VersaNail®HUMERAL NAILVERSANAIL®PROXIMAL HUMERAL LOCKING NAIL KITVERSANAIL®UNIVERSAL HUMERAL NAILPRECICE® Trauma Intramedullary Nail System InstrPRECICE® Trauma Nail SystemTalon™ DistalFix™ Humeral NailAtlas™ Humeral 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 ACCESSORIES527
HSBRod, Fixation, Intramedullary And Accessories299
JDSNAIL, FIXATION, BONE45
JDSNail, Fixation, Bone40
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENT1
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1

GMDN & GCC registration

  • GMDN code 38153 · implantable
  • Single‑use 100% · sterile 95% · Rx‑only 86% · 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) · 322Outer Diameter (Millimeter) · 165Length (Centimeter) · 72Angle (degree) · 33

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

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

809 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Humerus intramedullary nail", from 15 companies. The largest labeler is Stryker Gmbh with 23% of records.

Which FDA product codes apply?

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

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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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