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Device Explorer · FDA GUDID · GMDN 44805

Orthopaedic implantable-device cutter

A heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. This is a reus

US‑registered devices1,121in commercial distribution
Companies93labelers on GUDID
Single‑use2%of device records
Sterile1%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Depuy Spine, Llc12912%
Tecomet Inc.11110%
Avalign Technologies, Inc.706%
Nuvasive, Inc.696%
Sontec Instruments, Inc.626%
Teleflex Incorporated494%
Integra Lifesciences Production Corporation484%
Synthes Gmbh454%

Top labelers

CompanyDevicesShare
Depuy Spine, Llc12912%
Tecomet Inc.11110%
Avalign Technologies, Inc.706%
Nuvasive, Inc.696%
Sontec Instruments, Inc.626%
Teleflex Incorporated494%
Integra Lifesciences Production Corporation484%
Synthes Gmbh454%
Kls-Martin L.P.373%
Alphatec Spine, Inc.363%
Novo Surgical, Inc.323%
Ortho-Med, Inc.262%

Company = labeler of record on GUDID. 93 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aero-CNAXIA 3OASYSGAP ENDO-EXO MEDULLARY SYSTEMSIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMFASSIER-DUVAL TELESCOPIC IM SYSTEMSTILLE Wire CuttersCarboClear Posterior Cervical Screw SystemRod Cutter for 6mmCarboClear Pedicle Screw SystemInion FreedomScrew instrumentsInion® Universal instrumentsTRIO TRAUMADELTAImplant Modifier

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

FDA product codes

CodeNameDevices
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT277
HXZCUTTER, WIRE272
FZTCutter, Surgical119
FZTCUTTER, SURGICAL75
HXZCutter, Wire74
LXHOrthopedic manual surgical instrument72

GMDN & GCC registration

  • GMDN code 44805 · non‑implantable
  • Single‑use 2% · sterile 1% · Rx‑only 88% · 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) · 79Length (Centimeter) · 47Lumen/Inner Diameter (Millimeter) · 5Length (Millimeter) · 3Height (Millimeter) · 3Width (Millimeter) · 1

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

How many orthopaedic implantable-device cutter products are registered in the US?

1,121 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic implantable-device cutter", from 93 companies. The largest labeler is Depuy Spine, Llc with 12% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), HXZ (CUTTER, WIRE), FZT (Cutter, Surgical), FZT (CUTTER, SURGICAL)

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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