Consulting Wallah › Device Explorer › Other devices › Bone nail driver
Device Explorer · FDA GUDID · GMDN 35166

Bone nail driver

A hand-held manual surgical instrument designed to impart force on another instrument or directly on a bone fixation nail to insert the nail into tissue (i.e., to drive the nail into the intramedullary canal). It is typically made of high-grade stainless steel

US‑registered devices76in commercial distribution
Companies18labelers on GUDID
Single‑use12%of device records
Sterile0%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Medline Industries, Inc.1418%
Smith & Nephew, Inc.811%
Ascension Orthopedics, Inc.811%
Depuy Spine, Llc68%
Stryker Gmbh57%
Paragon 28, Inc.57%
Ortho Development Corporation57%
Biomet Orthopedics, Llc45%

Top labelers

CompanyDevicesShare
Medline Industries, Inc.1418%
Smith & Nephew, Inc.811%
Ascension Orthopedics, Inc.811%
Depuy Spine, Llc68%
Stryker Gmbh57%
Paragon 28, Inc.57%
Ortho Development Corporation57%
Biomet Orthopedics, Llc45%
Medos International Sàrl45%
Vb Spine Llc34%
Synthes Gmbh34%
Neoortho Produtos Ortopédicos S/A.34%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NAPhantom Hindfoot TTC/TC Nail SystemPhoenixWIN™ Trauma Fixation SystemsWIN NAIL PUSHER 0 CM OFFSETPanta 2 Arthrodesis Nail SystemWIN NAIL PUSHER 1.5 CM OFFSETPin DriverDOLOMITEn/aPRINCETONMJ-FLEXCENTRONAIL TITANIUM UNIVERSAL FEMORAL NAILING SYNAPA Access SystemRAVINE™ Access SystemRAVINE® Lateral Access System

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

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT37
LXHOrthopedic manual surgical instrument14
HXXSCREWDRIVER6
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5
LHXTrousers, anti-shock4
HSBRod, Fixation, Intramedullary And Accessories3

GMDN & GCC registration

  • GMDN code 35166 · non‑implantable
  • Single‑use 12% · sterile 0% · 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

No structured size data on the register.

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

How many bone nail driver products are registered in the US?

76 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone nail driver", from 18 companies. The largest labeler is Medline Industries, Inc. with 18% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), HXX (SCREWDRIVER), HSB (ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES)

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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