Consulting Wallah › Device Explorer › Orthopaedic implants › Internal spinal fixation procedure kit, reusable
Device Explorer · FDA GUDID · GMDN 64192

Internal spinal fixation procedure kit, reusable

A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage impl

US‑registered devices3,080in commercial distribution
Companies23labelers on GUDID
Single‑use7%of device records
Sterile1%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Nuvasive, Inc.2,06567%
Zavation Llc2348%
Ctl Medical Corporation1655%
Alpha Ai Co.,Ltd.1535%
Happe Spine, Llc1264%
Vy Spine Llc602%
Novapproach Spine Llc431%
4Web Medical411%

Top labelers

CompanyDevicesShare
Nuvasive, Inc.2,06567%
Zavation Llc2348%
Ctl Medical Corporation1655%
Alpha Ai Co.,Ltd.1535%
Happe Spine, Llc1264%
Vy Spine Llc602%
Novapproach Spine Llc431%
4Web Medical411%
Spineology Inc.341%
Indius Medical Technologies Private Limited311%
Camber Spine Technologies, Llc271%
Joimax Gmbh211%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EndoLIF®Intervertebral Spreadertrial implantraspatorium cageschaft breakerAWL (4.0 MM) FOR OPEN SURGERYAWL (3.0 MM) FOR OPEN SURGERYPROBE STRAIGHT (4.5 MM) FOR OPEN SURGERYPROBE STRAIGHT (3.5 MM) FOR OPEN SURGERYPROBE CURVED (4.5 MM) FOR OPEN SURGERYCHISEL LONG FOR OPEN SURGERYCHISEL SHORT FOR OPEN SURGERYCannulated Screwdriver tip for screw D3,5mm-L.1Screwdriver tip - screw D.3,5mm-L.18Screwdriver tip - screw D.3,5mm-L.20Screwdriver tip - screw D.3,5mm-L.22

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 INSTRUMENT1,146
LXHOrthopedic manual surgical instrument774
KWPAppliance, Fixation, Spinal Interlaminal361
LXHOrthopedic Manual Surgical Instrument338
MAXIntervertebral Fusion Device With Bone Graft, Lumbar304
MNIOrthosis, Spinal Pedicle Fixation298

GMDN & GCC registration

  • GMDN code 64192 · non‑implantable
  • Single‑use 7% · sterile 1% · Rx‑only 93% · 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) · 41Width (Millimeter) · 32Height (Millimeter) · 32Outer Diameter (Millimeter) · 9Length (Inch) · 1

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

How many internal spinal fixation procedure kit, reusable products are registered in the US?

3,080 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Internal spinal fixation procedure kit, reusable", from 23 companies. The largest labeler is Nuvasive, Inc. with 67% of records.

Which FDA product codes apply?

LXH (ORTHOPEDIC MANUAL SURGICAL INSTRUMENT), LXH (Orthopedic manual surgical instrument), KWP (Appliance, Fixation, Spinal Interlaminal), 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.

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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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