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Device Explorer · FDA GUDID · GMDN 15275

Bone awl, reusable

A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic

US‑registered devices2,379in commercial distribution
Companies194labelers on GUDID
Single‑use5%of device records
Sterile2%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.1546%
Highridge Medical, Llc1516%
Alphatec Spine, Inc.1285%
Stryker Corporation1185%
Synthes Gmbh1125%
Smith & Nephew, Inc.1054%
Seaspine Orthopedics Corporation924%
Vb Spine Llc773%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.1546%
Highridge Medical, Llc1516%
Alphatec Spine, Inc.1285%
Stryker Corporation1185%
Synthes Gmbh1125%
Smith & Nephew, Inc.1054%
Seaspine Orthopedics Corporation924%
Vb Spine Llc773%
Cg Medtech Co.,Ltd.582%
Spineart Sa522%
Silony Medical Gmbh512%
Zimmer Biomet Inc452%

Company = labeler of record on GUDID. 194 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AlphaVent, OmegaMonterey ALOASYSAviatorNavigation EnabledOMEGAXIA 4.5 Spinal SystemNAXia 3 System - SerratoXia 3 SystemINSTRUMENTXIA 3XIA 4.5XIAAVIATORREFLEX HYBRID

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

FDA product codes

CodeNameDevices
HWJAWL900
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT423
HWJAwl337
OLOOrthopedic stereotaxic instrument165
LXHOrthopedic Manual Surgical Instrument152
LXHOrthopedic manual surgical instrument133

GMDN & GCC registration

  • GMDN code 15275 · non‑implantable
  • Single‑use 5% · sterile 2% · Rx‑only 84% · 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 (Inch) · 58Length (Millimeter) · 37Outer Diameter (Millimeter) · 28Angle (degree) · 18Length (Centimeter) · 10Width (Millimeter) · 2

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

How many bone awl, reusable products are registered in the US?

2,379 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone awl, reusable", from 194 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 6% of records.

Which FDA product codes apply?

HWJ (AWL), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HWJ (Awl), OLO (Orthopedic stereotaxic 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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