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Device Explorer · FDA GUDID · GMDN 32850

Orthopaedic knife

A hand-held manual surgical instrument designed for cutting/shaping bone during an orthopaedic surgical intervention. It is typically a heavy, one-piece instrument with a sharp, single-edged, strong cutting blade at the distal end available in various shapes a

US‑registered devices632in commercial distribution
Companies33labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription81%Rx‑only share
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Share of device records

Medtronic Sofamor Danek, Inc.41165%
Globus Medical, Inc.477%
Life Instrument Corporation467%
Avalign Technologies, Inc.173%
Integra Lifesciences Production Corporation122%
Orthopaedic Implant Company, The91%
Alliance Partners Llc91%
Biomet Microfixation, Inc81%

Top labelers

CompanyDevicesShare
Medtronic Sofamor Danek, Inc.41165%
Globus Medical, Inc.477%
Life Instrument Corporation467%
Avalign Technologies, Inc.173%
Integra Lifesciences Production Corporation122%
Orthopaedic Implant Company, The91%
Alliance Partners Llc91%
Biomet Microfixation, Inc81%
Sontec Instruments, Inc.81%
Conmed Corporation71%
Teleflex Incorporated61%
Beaver-Visitec International, Inc.51%

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

Brand names on the register (sample)

N/AFanelli™Silicone PIPSurgical InstrumentsNAn/aMedtronic Reusable InstrumentsMAST QUADRANT™ Retractor SystemFANELLI HOOK KNIFEIllicoNovo Surgical Inc.DeGen Standard InstrumentationSigmagSourceEL CAPITAN4WEB Medical

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

FDA product codes

CodeNameDevices
FZTCUTTER, SURGICAL397
LXHOrthopedic manual surgical instrument148
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT65
LXHOrthopedic Manual Surgical Instrument41
HTSKNIFE, ORTHOPEDIC37
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE17

GMDN & GCC registration

  • GMDN code 32850 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 81% · 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) · 37Length (Inch) · 11Height (Millimeter) · 6Width (Millimeter) · 2

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

How many orthopaedic knife products are registered in the US?

632 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic knife", from 33 companies. The largest labeler is Medtronic Sofamor Danek, Inc. with 65% of records.

Which FDA product codes apply?

FZT (CUTTER, SURGICAL), LXH (Orthopedic manual surgical instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic Manual Surgical Instrument)

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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