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Device Explorer · FDA GUDID · GMDN 67570

External orthopaedic fixation system noninvasive component, reprocessed

A noninvasive, non-powered structural component of an external orthopaedic fixation system intended for bone/joint treatment (typically fracture stabilization, deformity correction, or distraction), in conjunction with an invasive bone pin (not included). It i

US‑registered devices387in commercial distribution
Companies3labelers on GUDID
Single‑use40%of device records
Sterile0%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Orthofix Srl23160%
Sterilmed, Inc.14838%
Fusion Orthopedics, Llc82%

Top labelers

CompanyDevicesShare
Orthofix Srl23160%
Sterilmed, Inc.14838%
Fusion Orthopedics, Llc82%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Metalogix RevolutionFuzeFix Max FTTRUE/LOK MONOLATERAL/BILATERAL FIXATORORTHOFIX GALAXY FIXATION SYSTEMORTHOFIX CHIMAERA Hip Fracture System - TrochantOrthofix TrueLok Hexapod System (TL-HEX) V2.0ORTHOFIX GALAXY WRISTORTHOFIX MODULSYSTEMADDITIONAL ACCESSORIES FOR THE ORTHOFIX SYSTEMWRIST FIXATION SYSTEMSNA

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 235
JDWPin, Fixation, Threaded184
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple 31
JECComponent, Traction, Invasive8
HRSPlate, Fixation, Bone6
LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple 4

GMDN & GCC registration

  • GMDN code 67570 · non‑implantable
  • Single‑use 40% · sterile 0% · Rx‑only 40% · 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) · 19Outer Diameter (Millimeter) · 11

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

How many external orthopaedic fixation system noninvasive component, reprocessed products are registered in the US?

387 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External orthopaedic fixation system noninvasive component, reprocessed", from 3 companies. The largest labeler is Orthofix Srl with 60% of records.

Which FDA product codes apply?

KTT (APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE ), JDW (Pin, Fixation, Threaded), KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple ), 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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