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Device Explorer · FDA GUDID · GMDN 32865

Orthopaedic implant driver

A hand-held manual surgical instrument designed to impart force to an orthopaedic implantable device that is inserted to fix or fasten together bones. The device is frequently used to insert devices such as screws, nails, plates, or wires that are used to fix

US‑registered devices2,692in commercial distribution
Companies93labelers on GUDID
Single‑use7%of device records
Sterile1%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.38014%
Seaspine Orthopedics Corporation36213%
Cg Medtech Co.,Ltd.33612%
Depuy Spine, Llc2369%
Ctl Medical Corporation1164%
Zavation Llc1114%
Biomet Orthopedics, Llc954%
Inno Holdings, Inc.833%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.38014%
Seaspine Orthopedics Corporation36213%
Cg Medtech Co.,Ltd.33612%
Depuy Spine, Llc2369%
Ctl Medical Corporation1164%
Zavation Llc1114%
Biomet Orthopedics, Llc954%
Inno Holdings, Inc.833%
Ace Surgical Supply Co., Inc.723%
Medos International Sàrl602%
In2Bones Usa, Llc532%
Genesys Orthopedics Systems Llc512%

Company = labeler of record on GUDID. 93 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tritanium TLXIA 3RADIUSXIA ELEGANCELITe PLATE SYSTEMTRIOAVIATOROASYSREFLEX HYBRIDLUXORXIA 4.5XIA IIXIASOLISINSTRUMENTXIA 4.5 System - XIA CT

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

FDA product codes

CodeNameDevices
HXXSCREWDRIVER745
HWRDRIVER, PROSTHESIS484
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT352
LXHOrthopedic Manual Surgical Instrument189
LXHOrthopedic manual surgical instrument178
HXXScrewdriver176

GMDN & GCC registration

  • GMDN code 32865 · non‑implantable
  • Single‑use 7% · sterile 1% · Rx‑only 91% · 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) · 65Length (Inch) · 18Outer Diameter (Millimeter) · 10Width (Millimeter) · 4Lumen/Inner Diameter (Millimeter) · 1Height (Millimeter) · 1

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

How many orthopaedic implant driver products are registered in the US?

2,692 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implant driver", from 93 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 14% of records.

Which FDA product codes apply?

HXX (SCREWDRIVER), HWR (DRIVER, PROSTHESIS), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), 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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