Device Explorer · FDA GUDID · GMDN 10455

Bone cutter

A strongly constructed, hand-held, surgical instrument designed to separate a bone into two parts through a cutting action. It typically consists of an instrument having one or two sharp robust blades that close over the bone and cut it. It is available in var

US‑registered devices1,247in commercial distribution
Companies52labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Alphatec Spine, Inc.69856%
Highridge Medical, Llc484%
Koros U.S.A., Inc.484%
Hygitech474%
Surgical Design, Inc.454%
Aesculap Ag363%
Surtex Instruments Ltd.353%
Ascension Orthopedics, Inc.323%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.69856%
Highridge Medical, Llc484%
Koros U.S.A., Inc.484%
Hygitech474%
Surgical Design, Inc.454%
Aesculap Ag363%
Surtex Instruments Ltd.353%
Ascension Orthopedics, Inc.323%
Medicon Eg. Chirurgiemechaniker-Genossenschaft272%
Aspen Surgical Products, Inc.242%
Zimmer, Inc.212%
Smith & Nephew, Inc.212%

Company = labeler of record on GUDID. 52 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

RELIANCE ALSTILLE Bone CuttersWilms Rongeur, 205mm O/L, 4mm BitePaton Bone Cutting Forceps, 140mm O/LMcIndoe Bone Cutting Forceps, Compound Action, 1Liston Bone Cutting Forceps, Straight Jaw, 200mmListon Bone Cutting Forcep, Angled Jaw- 165mm LeSurtexNAGAMMAAESCULAPMediconMIOSAequalis Reversed IITimberline Lateral Fusion SystemToro-L

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

FDA product codes

CodeNameDevices
HTZINSTRUMENT, CUTTING, ORTHOPEDIC513
HTQBROACH193
FZTCUTTER, SURGICAL102
HTXRongeur95
EJBHandle, Instrument, Dental47
OLOOrthopedic stereotaxic instrument44

GMDN & GCC registration

  • GMDN code 10455 · non‑implantable
  • Single‑use 2% · sterile 1% · Rx‑only 82% · OTC 4%
  • 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) · 130Height (Millimeter) · 117Length (Inch) · 59Length (Centimeter) · 23Outer Diameter (Millimeter) · 3

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

How many bone cutter products are registered in the US?

1,247 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Bone cutter", from 52 companies. The largest labeler is Alphatec Spine, Inc. with 56% of records.

Which FDA product codes apply?

HTZ (INSTRUMENT, CUTTING, ORTHOPEDIC), HTQ (BROACH), FZT (CUTTER, SURGICAL), HTX (Rongeur)

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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