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Device Explorer · FDA GUDID · GMDN 43084

Intervertebral-body internal spinal fixation system

An assembly of sterile implantable devices designed to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The system components are typically made of medical grade titanium and consist of vari

US‑registered devices975in commercial distribution
Companies5labelers on GUDID
Single‑use99%of device records
Sterile88%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Choice Spine, Lp78981%
Cg Medtech Co.,Ltd.9910%
Tyber Medical, Llc475%
Zimmer Spine, Inc.263%
Biomet Spine Llc141%

Top labelers

CompanyDevicesShare
Choice Spine, Lp78981%
Cg Medtech Co.,Ltd.9910%
Tyber Medical, Llc475%
Zimmer Spine, Inc.263%
Biomet Spine Llc141%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BP®BAK®Fortitude®LENTUR CABLE SYSTEMLentur™ Cable SystemTIGER SHARK SYSTEMTiger Shark Spinal SystemOctane StraightHarrier SATiger Shark SystemHARRIER-SA Lumbar Interbody SystemHARRIER-SA Lumber Interbody SystemBLACKHAWK Cervical Spacer SystemTOMCAT Cervical Spinal SystemTomcat Cervical Spinal SystemTyber Medical

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

FDA product codes

CodeNameDevices
MAXIntervertebral fusion device with bone graft, lumbar482
OVEIntervertebral fusion device with integrated fixation, cervi316
OVDIntervertebral fusion device with integrated fixation, lumba115
KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY99
KWQAppliance, Fixation, Spinal Intervertebral Body47
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE12

GMDN & GCC registration

  • GMDN code 43084 · non‑implantable
  • Single‑use 99% · sterile 88% · Rx‑only 100% · 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) · 771Height (Millimeter) · 771Depth (Millimeter) · 416Length (Millimeter) · 369Outer Diameter (Millimeter) · 14

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

How many intervertebral-body internal spinal fixation system products are registered in the US?

975 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Intervertebral-body internal spinal fixation system", from 5 companies. The largest labeler is Choice Spine, Lp with 81% of records.

Which FDA product codes apply?

MAX (Intervertebral fusion device with bone graft, lumbar), OVE (Intervertebral fusion device with integrated fixation, cervi), OVD (Intervertebral fusion device with integrated fixation, lumba), KWQ (APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY)

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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