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Device Explorer · FDA GUDID · GMDN 48164

Cervical total intervertebral disc prosthesis, modular

An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plate

US‑registered devices281in commercial distribution
Companies10labelers on GUDID
Single‑use99%of device records
Sterile98%labelled sterile
Prescription88%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Centinel Spine, Llc7226%
Nuvasive, Inc.6423%
Globus Medical, Inc.3412%
Ldr Spine Usa, Inc.3011%
Medtronic Sofamor Danek, Inc.2710%
Synthes (U.S.A.) Lp166%
Synergy Spine Solutions Inc124%
Spinal Kinetics, Inc.104%

Top labelers

CompanyDevicesShare
Centinel Spine, Llc7226%
Nuvasive, Inc.6423%
Globus Medical, Inc.3412%
Ldr Spine Usa, Inc.3011%
Medtronic Sofamor Danek, Inc.2710%
Synthes (U.S.A.) Lp166%
Synergy Spine Solutions Inc124%
Spinal Kinetics, Inc.104%
Spineart Sa93%
Zimmer Biomet Inc72%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Mobi-C Plug & Fit USMobi-CMobi-C® Plug & Fit USMobi-C® Plug & Fit USSECURE-CPCMSimplifySimplify® Cervical Artificial DiscProdisc C SKProdisc C VivoProdisc C NovaProdisc CM6-CPRESTIGE® Cervical Disc SystemPRESTIGE LP™PRESTIGE® LP Cervical Disc System

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

FDA product codes

CodeNameDevices
MJOProsthesis, Intervertebral Disc163
MJOPROSTHESIS, INTERVERTEBRAL DISC81
MJOProsthesis, intervertebral disc39

GMDN & GCC registration

  • GMDN code 48164 · implantable
  • Single‑use 99% · sterile 98% · Rx‑only 88% · 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) · 110Depth (Millimeter) · 99Width (Millimeter) · 81Angle (degree) · 26Outer Diameter (Millimeter) · 5Length (Millimeter) · 2

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

How many cervical total intervertebral disc prosthesis, modular products are registered in the US?

281 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Cervical total intervertebral disc prosthesis, modular", from 10 companies. The largest labeler is Centinel Spine, Llc with 26% of records.

Which FDA product codes apply?

MJO (Prosthesis, Intervertebral Disc), MJO (PROSTHESIS, INTERVERTEBRAL DISC), MJO (Prosthesis, intervertebral disc)

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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