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Device Explorer · FDA GUDID · GMDN 12846

Plastic surgery osteotome

A surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of

US‑registered devices1,538in commercial distribution
Companies33labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription83%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation18612%
Avalign Technologies, Inc.17111%
Boss Instruments, Ltd., Inc.15710%
Ambler Surgical Corp.14710%
Sklar Corporation956%
Novo Surgical, Inc.926%
Spiggle & Theis Medizintechnik Gmbh815%
Medicon Eg. Chirurgiemechaniker-Genossenschaft745%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation18612%
Avalign Technologies, Inc.17111%
Boss Instruments, Ltd., Inc.15710%
Ambler Surgical Corp.14710%
Sklar Corporation956%
Novo Surgical, Inc.926%
Spiggle & Theis Medizintechnik Gmbh815%
Medicon Eg. Chirurgiemechaniker-Genossenschaft745%
Integra Microfrance644%
Marina Medical Instruments, Inc.604%
Hayden Medical, Inc.554%
Sontec Instruments, Inc.503%

Company = labeler of record on GUDID. 33 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Dunn Dautrey osteotomeHookOsteotome Premium LineCinelli osteotomeAnderson-Neivert osteotome for lateralHerberhold osteotomeHerberhold osteotome for lateralWalter osteotomeWurm osteotomeMasing osteotome for lateral osteotomyMini osteotomeMasing osteotome, 2 guards, 10 mmRubin osteotomeCottle osteotomeCottle osteotome with single guardMasing osteotome for lateral

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

FDA product codes

CodeNameDevices
HWMOSTEOTOME895
GFIOSTEOTOME, MANUAL255
EMMCHISEL, OSTEOTOME, SURGICAL148
HWMOsteotome75
GFIOsteotome, Manual47
FZOCHISEL, SURGICAL, MANUAL39

GMDN & GCC registration

  • GMDN code 12846 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 83% · 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) · 95Width (Millimeter) · 84Length (Centimeter) · 36Outer Diameter (Millimeter) · 2

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

How many plastic surgery osteotome products are registered in the US?

1,538 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Plastic surgery osteotome", from 33 companies. The largest labeler is Integra Lifesciences Production Corporation with 12% of records.

Which FDA product codes apply?

HWM (OSTEOTOME), GFI (OSTEOTOME, MANUAL), EMM (CHISEL, OSTEOTOME, SURGICAL), HWM (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.

How do I get quotes?

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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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