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Device Explorer · FDA GUDID · GMDN 35095

Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with gui

US‑registered devices10,394in commercial distribution
Companies259labelers on GUDID
Single‑use4%of device records
Sterile1%labelled sterile
Prescription87%Rx‑only share
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Share of device records

Smith & Nephew, Inc.7637%
Arthrex, Inc.7397%
Biomet Orthopedics, Llc6286%
Synthes Gmbh5415%
Medtronic Sofamor Danek, Inc.3914%
Osstem Implant Co., Ltd.3443%
Globus Medical, Inc.2853%
Jeil Medical Corporation2683%

Top labelers

CompanyDevicesShare
Smith & Nephew, Inc.7637%
Arthrex, Inc.7397%
Biomet Orthopedics, Llc6286%
Synthes Gmbh5415%
Medtronic Sofamor Danek, Inc.3914%
Osstem Implant Co., Ltd.3443%
Globus Medical, Inc.2853%
Jeil Medical Corporation2683%
Stryker Gmbh2532%
Seaspine Orthopedics Corporation2532%
Alphatec Spine, Inc.2482%
Exactech, Inc.2342%

Company = labeler of record on GUDID. 259 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2, PANGEAIconixPANGEAKNOTILUS+VARIAXGAMMANAINSTRUMENTN/AREUNIONCinchLock FlexEASYSTEPAVIATOROASYSREFLEX HYBRIDAXSOS

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

FDA product codes

CodeNameDevices
FZXGuide, surgical, instrument3,022
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,329
FZXGuide, Surgical, Instrument1,165
LXHOrthopedic manual surgical instrument645
NDPAccessories, Implant, Dental, Endosseous642
LXHOrthopedic Manual Surgical Instrument591

GMDN & GCC registration

  • GMDN code 35095 · non‑implantable
  • Single‑use 4% · sterile 1% · Rx‑only 87% · 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

Outer Diameter (Millimeter) · 387Length (Millimeter) · 261Height (Millimeter) · 183Lumen/Inner Diameter (Millimeter) · 136Width (Millimeter) · 125Angle (degree) · 46

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

How many surgical drill guide, reusable products are registered in the US?

10,394 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical drill guide, reusable", from 259 companies. The largest labeler is Smith & Nephew, Inc. with 7% of records.

Which FDA product codes apply?

FZX (Guide, surgical, instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), FZX (Guide, 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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