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Device Explorer · FDA GUDID · GMDN 44788

Spinal implant trial

A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appr

US‑registered devices38,513in commercial distribution
Companies92labelers on GUDID
Single‑use9%of device records
Sterile2%labelled sterile
Prescription91%Rx‑only share
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Share of device records

Alphatec Spine, Inc.4,01610%
Degen Medical, Inc.3,1388%
Summit Spine Llc2,8667%
Nuvasive, Inc.2,5047%
Seaspine Orthopedics Corporation2,1366%
Medtronic Sofamor Danek, Inc.1,6604%
Altus Spine, Llc1,5054%
Globus Medical, Inc.1,4474%

Top labelers

CompanyDevicesShare
Alphatec Spine, Inc.4,01610%
Degen Medical, Inc.3,1388%
Summit Spine Llc2,8667%
Nuvasive, Inc.2,5047%
Seaspine Orthopedics Corporation2,1366%
Medtronic Sofamor Danek, Inc.1,6604%
Altus Spine, Llc1,5054%
Globus Medical, Inc.1,4474%
Highridge Medical, Llc1,3664%
Astura Medical1,2033%
Captiva Spine, Inc.1,1143%
Meditech Spine, Llc9703%

Company = labeler of record on GUDID. 92 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Aero CTritanium TLTritanium CARIAAVS NAVIGATORAVSRELIANCERELIANCE CRELIANCE ALAVS Anchor-C Cervical Cage SystemAero-CCarboClear Cervical Cage / VBR SystemCarboClear Lumbar Cage SystemAxis Spine Technologies ALIF System InstrumentAxis Spine Technologies ALIF“Paonan” Orthopedic Manual Surgical Instrument (

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, lumbar8,932
MAXIntervertebral Fusion Device With Bone Graft, Lumbar8,068
ODPIntervertebral fusion device with bone graft, cervical4,678
HWTTEMPLATE4,121
OVDIntervertebral fusion device with integrated fixation, lumba3,289
LXHOrthopedic Manual Surgical Instrument3,161

GMDN & GCC registration

  • GMDN code 44788 · non‑implantable
  • Single‑use 9% · sterile 2% · Rx‑only 91% · 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) · 15,610Width (Millimeter) · 13,408Angle (degree) · 10,268Length (Millimeter) · 8,323Depth (Millimeter) · 4,370Outer Diameter (Millimeter) · 180

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

How many spinal implant trial products are registered in the US?

38,513 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Spinal implant trial", from 92 companies. The largest labeler is Alphatec Spine, Inc. with 10% of records.

Which FDA product codes apply?

MAX (Intervertebral fusion device with bone graft, lumbar), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), ODP (Intervertebral fusion device with bone graft, cervical), HWT (TEMPLATE)

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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