Consulting Wallah › Device Explorer › Procedure kits & trays › General internal orthopaedic fixation system impla
Device Explorer · FDA GUDID · GMDN 44759

General internal orthopaedic fixation system implantation kit

A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes v

US‑registered devices20,580in commercial distribution
Companies122labelers on GUDID
Single‑use7%of device records
Sterile3%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Kyocera Medical Technologies, Inc.3,17115%
Vb Spine Llc2,96214%
Nexxt Spine, Llc2,90714%
Osteomed Llc1,7959%
Spinecraft, Llc1,4837%
Acumed Llc1,2916%
Smith & Nephew, Inc.6373%
Medtronic Sofamor Danek, Inc.5543%

Top labelers

CompanyDevicesShare
Kyocera Medical Technologies, Inc.3,17115%
Vb Spine Llc2,96214%
Nexxt Spine, Llc2,90714%
Osteomed Llc1,7959%
Spinecraft, Llc1,4837%
Acumed Llc1,2916%
Smith & Nephew, Inc.6373%
Medtronic Sofamor Danek, Inc.5543%
Gm Dos Reis Industria E Comercio Ltda4482%
Stryker Corporation4392%
Biedermann Motech Gmbh & Co. Kg4152%
Ulrich Gmbh & Co. Kg3472%

Company = labeler of record on GUDID. 122 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

T2VARIAXXia 4.5LITe DecompressionARIAXia 3ES2SerratoTritanium CACP 1Monterey ALXIA 3NAOASYSPROReliance

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 Instrument5,744
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT4,463
MAXIntervertebral fusion device with bone graft, lumbar3,020
ODPIntervertebral fusion device with bone graft, cervical2,530
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE1,834
LXHOrthopedic manual surgical instrument1,243

GMDN & GCC registration

  • GMDN code 44759 · non‑implantable
  • Single‑use 7% · sterile 3% · Rx‑only 89% · 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

Height (Millimeter) · 3,916Width (Millimeter) · 3,913Length (Millimeter) · 3,408Angle (degree) · 2,538Depth (Millimeter) · 770Outer Diameter (Millimeter) · 472

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How many general internal orthopaedic fixation system implantation kit products are registered in the US?

20,580 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "General internal orthopaedic fixation system implantation kit", from 122 companies. The largest labeler is Kyocera Medical Technologies, Inc. with 15% of records.

Which FDA product codes apply?

LXH (Orthopedic Manual Surgical Instrument), LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), MAX (Intervertebral fusion device with bone graft, lumbar), ODP (Intervertebral fusion device with bone graft, cervical)

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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