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Device Explorer · FDA GUDID · GMDN 10825

Orthopaedic chisel

A hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. 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 instrumen

US‑registered devices3,062in commercial distribution
Companies122labelers on GUDID
Single‑use3%of device records
Sterile1%labelled sterile
Prescription78%Rx‑only share
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Share of device records

Medicon Eg. Chirurgiemechaniker-Genossenschaft34911%
Aesculap Ag1555%
Ambler Surgical Corp.1134%
Highridge Medical, Llc1063%
Alphatec Spine, Inc.993%
Smith & Nephew, Inc.953%
Novo Surgical, Inc.933%
Integra Lifesciences Production Corporation873%

Top labelers

CompanyDevicesShare
Medicon Eg. Chirurgiemechaniker-Genossenschaft34911%
Aesculap Ag1555%
Ambler Surgical Corp.1134%
Highridge Medical, Llc1063%
Alphatec Spine, Inc.993%
Smith & Nephew, Inc.953%
Novo Surgical, Inc.933%
Integra Lifesciences Production Corporation873%
Surtex Instruments Ltd.833%
Aspen Surgical Products, Inc.783%
Sklar Corporation773%
Schobell Industrial Ltda732%

Company = labeler of record on GUDID. 122 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

INSTRUMENTRELIANCERENOVATIONPOLARSTEMSL-PLUSSTILLE GougesSTILLE ChiselsChisel, cannulatedCapener Chisel, Straight, 260mm O/L, 30mm WidthCapener Chisel, Straight, 260mm O/L, 8mm WidthCapener Chisel, Straight, 260mm O/L, 25mm WidthCapener Chisel, Straight, 260mm O/L, 20mm WidthCapener Chisel, Straight, 260mm O/L, 15mm WidthCapener Chisel, Straight, 260mm O/L, 12mm WidthCapener Chisel, Straight, 260mm O/L, 10mm WidthCapener Chisel, Straight, 260mm O/L, 6mm Width

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

FDA product codes

CodeNameDevices
FZOCHISEL, SURGICAL, MANUAL1,022
KDGChisel (Osteotome)289
GDHGOUGE, SURGICAL, GENERAL & PLASTIC SURGERY219
FZOChisel, Surgical, Manual216
LXHOrthopedic Manual Surgical Instrument177
HWMOSTEOTOME165

GMDN & GCC registration

  • GMDN code 10825 · non‑implantable
  • Single‑use 3% · sterile 1% · Rx‑only 78% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Millimeter) · 137Length (Inch) · 106Length (Millimeter) · 52Length (Centimeter) · 31Height (Millimeter) · 28Width (Inch) · 25

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

How many orthopaedic chisel products are registered in the US?

3,062 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic chisel", from 122 companies. The largest labeler is Medicon Eg. Chirurgiemechaniker-Genossenschaft with 11% of records.

Which FDA product codes apply?

FZO (CHISEL, SURGICAL, MANUAL), KDG (Chisel (Osteotome)), GDH (GOUGE, SURGICAL, GENERAL & PLASTIC SURGERY), FZO (Chisel, Surgical, Manual)

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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