Consulting Wallah › Device Explorer › Other devices › Orthopaedic surgical distractor, external
Device Explorer · FDA GUDID · GMDN 62787

Orthopaedic surgical distractor, external

A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be sta

US‑registered devices184in commercial distribution
Companies20labelers on GUDID
Single‑use15%of device records
Sterile0%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Innomed, Inc.4927%
Astura Medical2614%
Innovative Medical Products, Inc2514%
In2Bones Usa, Llc1810%
Gsource Llc127%
Arthrex, Inc.84%
Modern Surgical Instruments Llc84%
Treace Medical Concepts, Inc.74%

Top labelers

CompanyDevicesShare
Innomed, Inc.4927%
Astura Medical2614%
Innovative Medical Products, Inc2514%
In2Bones Usa, Llc1810%
Gsource Llc127%
Arthrex, Inc.84%
Modern Surgical Instruments Llc84%
Treace Medical Concepts, Inc.74%
Life Instrument Corporation53%
Avalign Technologies, Inc.53%
Ortho-Med, Inc.42%
Ambler Surgical Corp.42%

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

Brand names on the register (sample)

NAArthrex®Gauthier BiomedicalCompressor & DistractorX-PACLamina SpreaderARTEMIS FUZESIRIONHALF DOMEgSourceInnomed, Inc.Innomed, INc.MSICompressor / DistractorIn2Bones5MS

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

FDA product codes

CodeNameDevices
GADRetractor59
FWZOperating Room Accessories Table Tray28
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba26
KWQAppliance, Fixation, Spinal Intervertebral Body26
MAXIntervertebral Fusion Device With Bone Graft, Lumbar26
LXHOrthopedic Manual Surgical Instrument25

GMDN & GCC registration

  • GMDN code 62787 · non‑implantable
  • Single‑use 15% · sterile 0% · Rx‑only 47% · 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

Width (Millimeter) · 26

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

How many orthopaedic surgical distractor, external products are registered in the US?

184 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic surgical distractor, external", from 20 companies. The largest labeler is Innomed, Inc. with 27% of records.

Which FDA product codes apply?

GAD (Retractor), FWZ (Operating Room Accessories Table Tray), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba), KWQ (Appliance, Fixation, Spinal Intervertebral Body)

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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