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Device Explorer · FDA GUDID · GMDN 35315

Orthopaedic retractor

A hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.

US‑registered devices406in commercial distribution
Companies11labelers on GUDID
Single‑use36%of device records
Sterile9%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Seaspine Orthopedics Corporation14736%
Biomet Microfixation, Inc10726%
Smith & Nephew, Inc.6717%
Globus Medical, Inc.5113%
Kirwan Surgical Products Llc92%
T.A.G Medical Products Agricultural Cooperative Association92%
Orthomedflex Llc82%
Nuvasive Specialized Orthopedics, Inc.31%

Top labelers

CompanyDevicesShare
Seaspine Orthopedics Corporation14736%
Biomet Microfixation, Inc10726%
Smith & Nephew, Inc.6717%
Globus Medical, Inc.5113%
Kirwan Surgical Products Llc92%
T.A.G Medical Products Agricultural Cooperative Association92%
Orthomedflex Llc82%
Nuvasive Specialized Orthopedics, Inc.31%
Zimmer, Inc.20%
Quandary Medical Llc20%
Orthofix Srl10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

COFIELDNEERN/AUnicondylar Interpositional SpacerJourney IILegionPolarAnthologyHips-MISCANTHOLOGYNo BrandEndo-shouldersHips-MiscR3Hips-miscNA

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

FDA product codes

CodeNameDevices
GADRETRACTOR205
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT105
EIGRETRACTOR, ALL TYPES49
LXHOrthopedic Manual Surgical Instrument11
GADRetractor11
HAOInstrument, Surgical, Non-Powered9

GMDN & GCC registration

  • GMDN code 35315 · non‑implantable
  • Single‑use 36% · sterile 9% · Rx‑only 83% · 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) · 19Length (Millimeter) · 12Length (Inch) · 7Height (Millimeter) · 3

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

How many orthopaedic retractor products are registered in the US?

406 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic retractor", from 11 companies. The largest labeler is Seaspine Orthopedics Corporation with 36% of records.

Which FDA product codes apply?

GAD (RETRACTOR), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), EIG (RETRACTOR, ALL TYPES), LXH (Orthopedic Manual Surgical Instrument)

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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