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Device Explorer · FDA GUDID · GMDN 12844

Orthopaedic osteotome

A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the inst

US‑registered devices8,077in commercial distribution
Companies146labelers on GUDID
Single‑use4%of device records
Sterile1%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Surgical Direct, Inc.5367%
Avalign Technologies, Inc.4996%
Ambler Surgical Corp.4255%
Alphatec Spine, Inc.3224%
Novo Surgical, Inc.3214%
Life Instrument Corporation2834%
Sklar Corporation2693%
Innomed, Inc.2393%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.5367%
Avalign Technologies, Inc.4996%
Ambler Surgical Corp.4255%
Alphatec Spine, Inc.3224%
Novo Surgical, Inc.3214%
Life Instrument Corporation2834%
Sklar Corporation2693%
Innomed, Inc.2393%
Aspen Surgical Products, Inc.2333%
Med Saver, Inc.2303%
Surtex Instruments Ltd.2263%
Kls-Martin L.P.2213%

Company = labeler of record on GUDID. 146 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Posterior TLIFINSTRUMENTRELIANCE ALRELIANCERELIANCE LITeNACS-PLUS/CSL-PLUSDr.Paleys Osteotomy SystemAstra Tech Implant System®STILLE OsteotomesOsteotome - Capener, Straight - 6mm Width with GSmith Petersen Osteotome, Curved, 205mm O/L, 20mSmith Petersen Osteotome, Curved, 205mm O/L, 15mSmith Petersen Osteotome, Curved, 205mm O/L, 13mSmith Petersen Osteotome, Curved, 205mm O/L, 6mmCapener Osteotome, Curved, 260mm O/L, 20mm Width

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

FDA product codes

CodeNameDevices
HWMOSTEOTOME2,411
HWMOsteotome1,393
GFIOSTEOTOME, MANUAL1,022
KDGCHISEL (OSTEOTOME)604
KDGChisel (Osteotome)317
HAOINSTRUMENT, SURGICAL, NON-POWERED294

GMDN & GCC registration

  • GMDN code 12844 · non‑implantable
  • Single‑use 4% · sterile 1% · Rx‑only 64% · 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) · 492Width (Millimeter) · 280Width (Inch) · 172Length (Centimeter) · 168Length (Millimeter) · 78Outer Diameter (Millimeter) · 31

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

How many orthopaedic osteotome products are registered in the US?

8,077 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic osteotome", from 146 companies. The largest labeler is Surgical Direct, Inc. with 7% of records.

Which FDA product codes apply?

HWM (OSTEOTOME), HWM (Osteotome), GFI (OSTEOTOME, MANUAL), KDG (CHISEL (OSTEOTOME))

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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