Consulting Wallah › Device Explorer › Procedure kits & trays › Orthopaedic surgical procedure kit, non-medicated,
Device Explorer · FDA GUDID · GMDN 44054

Orthopaedic surgical procedure kit, non-medicated, reusable

A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals.

US‑registered devices24,288in commercial distribution
Companies102labelers on GUDID
Single‑use3%of device records
Sterile2%labelled sterile
Prescription40%Rx‑only share
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Share of device records

Medacta International Sa11,26646%
Precision Spine, Inc.1,9028%
Signus Medizintechnik Gmbh1,8918%
Globus Medical, Inc.1,5416%
Clariance7073%
Orthopediatrics Corp.6993%
Fx Solutions6763%
Razek Equipamentos Ltda5972%

Top labelers

CompanyDevicesShare
Medacta International Sa11,26646%
Precision Spine, Inc.1,9028%
Signus Medizintechnik Gmbh1,8918%
Globus Medical, Inc.1,5416%
Clariance7073%
Orthopediatrics Corp.6993%
Fx Solutions6763%
Razek Equipamentos Ltda5972%
Spinevision4322%
Ngmedical Gmbh4232%
Orthalign, Inc.3541%
Implanet3491%

Company = labeler of record on GUDID. 102 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

MMF AXSNAGAMMAVARIAXHOFFMANNPROASNISAXSOSVariAxBIXCUTT2PROFYLEOMEGAAgili-C Surgical Toolset Full Sterilization TrayAgili-C ToolsetAgili-C Quick Connect Handle

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 Instrument14,629
LXHOrthopedic manual surgical instrument1,734
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT1,523
OLOOrthopedic Stereotaxic Instrument479
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented477
HWTTemplate442

GMDN & GCC registration

  • GMDN code 44054 · non‑implantable
  • Single‑use 3% · sterile 2% · Rx‑only 40% · 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

Width (Millimeter) · 546Length (Millimeter) · 540Height (Millimeter) · 455Outer Diameter (Millimeter) · 381Length (Centimeter) · 238Angle (degree) · 161

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

How many orthopaedic surgical procedure kit, non-medicated, reusable products are registered in the US?

24,288 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthopaedic surgical procedure kit, non-medicated, reusable", from 102 companies. The largest labeler is Medacta International Sa with 46% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), LXH (Orthopedic manual surgical instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), OLO (Orthopedic Stereotaxic 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.

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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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