Consulting Wallah › Device Explorer › Orthopaedic implants › Lumbar total intervertebral disc prosthesis
Device Explorer · FDA GUDID · GMDN 48165

Lumbar total intervertebral disc prosthesis

An implantable device designed to replace a dysfunctional intervertebral disc in the lumbar spine. It most commonly has a two-plate design, one plate attaching to the vertebra above and the other to the vertebra below and may have a compressible core component

US‑registered devices87in commercial distribution
Companies5labelers on GUDID
Single‑use55%of device records
Sterile74%labelled sterile
Prescription100%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Highridge Medical, Llc3641%
Altus Spine, Llc2023%
Centinel Spine, Llc1821%
Synthes (U.S.A.) Lp1011%
Genesys Orthopedics Systems Llc33%

Top labelers

CompanyDevicesShare
Highridge Medical, Llc3641%
Altus Spine, Llc2023%
Centinel Spine, Llc1821%
Synthes (U.S.A.) Lp1011%
Genesys Orthopedics Systems Llc33%

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

Brand names on the register (sample)

ActivLBrickyard Stand-Alone ALIFIndy StandaloneProdisc L3DP Lumbar InterbodyProDisc

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 disc52
MJOPROSTHESIS, INTERVERTEBRAL DISC32
MAXIntervertebral Fusion Device With Bone Graft, Lumbar23
OVDIntervertebral Fusion Device With Integrated Fixation, Lumba20
MJOProsthesis, Intervertebral Disc18
MQPSpinal Vertebral Body Replacement Device3

GMDN & GCC registration

  • GMDN code 48165 · implantable
  • Single‑use 55% · sterile 74% · 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

No structured size data on the register.

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

How many lumbar total intervertebral disc prosthesis products are registered in the US?

87 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Lumbar total intervertebral disc prosthesis", from 5 companies. The largest labeler is Highridge Medical, Llc with 41% of records.

Which FDA product codes apply?

MJO (Prosthesis, intervertebral disc), MJO (PROSTHESIS, INTERVERTEBRAL DISC), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), OVD (Intervertebral Fusion Device With Integrated Fixation, Lumba)

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.

How do I get quotes?

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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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