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Device Explorer · FDA GUDID · GMDN 62896

Orthopaedic osteotome blade, single-use

A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curv

US‑registered devices432in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile6%labelled sterile
Prescription11%Rx‑only share
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Share of device records

Imedicom Co., Ltd.27564%
Depuy (Ireland)5112%
Shukla Medical409%
Spierings Orthopaedics B.V.266%
Rp Medical Inc164%
Smith & Nephew, Inc.123%
Arthrex, Inc.31%
Nuvasive Specialized Orthopedics, Inc.31%

Top labelers

CompanyDevicesShare
Imedicom Co., Ltd.27564%
Depuy (Ireland)5112%
Shukla Medical409%
Spierings Orthopaedics B.V.266%
Rp Medical Inc164%
Smith & Nephew, Inc.123%
Arthrex, Inc.31%
Nuvasive Specialized Orthopedics, Inc.31%
Osteocentric Technologies, Inc.20%
Zimmer, Inc.10%
Tightline Development, Llc10%
Simplex Designs, Llc10%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RENOVATIONExodus Revision Hip SystemArthrex®PRECICE Osteotome Blade, CurvedPRECICE Osteotome Blade, 6mmPRECICE Osteotome Blade, 12mmRP MedicalExodus RevisionBladeX Blade SterileBladeX BladeWatson Extraction SystemShukla Blade S9BLADEShukla Shoulder Blade S9SHLDR-BLADESTRADIS HEALTHCAREIMEDICOM HIGH SPEED BLADEKINCISE™ System Acetabular Cup Extraction Finish

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

FDA product codes

CodeNameDevices
HTTBurr, Orthopedic275
LXHOrthopedic manual surgical instrument51
HWMOsteotome41
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Acces26
GFIOsteotome, Manual16
JDGProsthesis, hip, femoral component, cemented, metal12

GMDN & GCC registration

  • GMDN code 62896 · non‑implantable
  • Single‑use 100% · sterile 6% · Rx‑only 11% · 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 (Millimeter) · 2

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

How many orthopaedic osteotome blade, single-use products are registered in the US?

432 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic osteotome blade, single-use", from 13 companies. The largest labeler is Imedicom Co., Ltd. with 64% of records.

Which FDA product codes apply?

HTT (Burr, Orthopedic), LXH (Orthopedic manual surgical instrument), HWM (Osteotome), HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Acces)

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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