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Device Explorer · FDA GUDID · GMDN 35647

External orthopaedic fixation system, reusable

An assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable c

US‑registered devices712in commercial distribution
Companies20labelers on GUDID
Single‑use28%of device records
Sterile1%labelled sterile
Prescription98%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Orthofix Srl30042%
Wright Medical Technology, Inc.11917%
Ascension Orthopedics, Inc.8212%
Smith & Nephew, Inc.7210%
Tdm Co., Ltd.598%
Zimmer Orthopaedic Surgical Products, Inc.203%
Reison Medical Ab132%
Metalogix132%

Top labelers

CompanyDevicesShare
Orthofix Srl30042%
Wright Medical Technology, Inc.11917%
Ascension Orthopedics, Inc.8212%
Smith & Nephew, Inc.7210%
Tdm Co., Ltd.598%
Zimmer Orthopaedic Surgical Products, Inc.203%
Reison Medical Ab132%
Metalogix132%
Biomet Orthopedics, Llc122%
Zimmer, Inc.51%
Stryker Leibinger Gmbh & Co. Kg41%
Jeil Medical Corporation30%

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

Brand names on the register (sample)

HOFFMANNNAHumerus traction SetTraction unitCounter traction postHand fixationStretch deviceTibia supportKnee arthroscopy supportReisonJet-XILIZAROVOTHER EXTERNAL FIXATIONHEX-FIXILIZAROV SYSTEMSCALANDRUCCIO II

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

FDA product codes

CodeNameDevices
KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE 225
JDWPin, Fixation, Threaded156
JDWPIN, FIXATION, THREADED99
JECComponent, Traction, Invasive71
LXHOrthopedic Manual Surgical Instrument70
HSBRod, Fixation, Intramedullary And Accessories67

GMDN & GCC registration

  • GMDN code 35647 · implantable
  • Single‑use 28% · sterile 1% · Rx‑only 98% · 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) · 58Width (Millimeter) · 36Outer Diameter (Millimeter) · 34Lumen/Inner Diameter (Millimeter) · 19Length (Centimeter) · 16Length (Inch) · 11

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

How many external orthopaedic fixation system, reusable products are registered in the US?

712 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External orthopaedic fixation system, reusable", from 20 companies. The largest labeler is Orthofix Srl with 42% of records.

Which FDA product codes apply?

KTT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE ), JDW (Pin, Fixation, Threaded), JDW (PIN, FIXATION, THREADED), JEC (Component, Traction, Invasive)

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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