Consulting Wallah › Device Explorer › Orthopaedic implants › Facet joint prosthesis
Device Explorer · FDA GUDID · GMDN 60792

Facet joint prosthesis

A sterile implantable device intended to resurface and/or replace a degenerative or otherwise diseased vertebral facet (apophyseal, zygapophyseal) joint. It typically consists of small plate-like metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] device intend

US‑registered devices113in commercial distribution
Companies2labelers on GUDID
Single‑use99%of device records
Sterile2%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Surgentec, Llc6759%
Genesys Orthopedics Systems Llc4641%

Top labelers

CompanyDevicesShare
Surgentec, Llc6759%
Genesys Orthopedics Systems Llc4641%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ION Facet Screw SystemPin PullerION implant caddy largeION implant caddy smallION Sterilization TrayFacet Screw Drill GuidePlastic Drill GuideMedium AO Ratcheting T Handle4.5mm Drill Bit - Facet Screw5.5mm Drill Bit - Long5.0mm Drill Bit - LongFacet Screw InserterMedium Axial AO Ratcheting Handle5.0mm Drill Bit5.5mm Drill Bit4.5mm Drill Bit - Long

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

FDA product codes

CodeNameDevices
MRWSystem, Facet Screw Spinal Device68
OVEIntervertebral Fusion Device With Integrated Fixation, Cervi46
FMFSyringe, Piston1
HTRRasp1

GMDN & GCC registration

  • GMDN code 60792 · non‑implantable
  • Single‑use 99% · sterile 2% · 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

Height (Millimeter) · 46

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

No closely related category with 50+ devices.

How many facet joint prosthesis products are registered in the US?

113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Facet joint prosthesis", from 2 companies. The largest labeler is Surgentec, Llc with 59% of records.

Which FDA product codes apply?

MRW (System, Facet Screw Spinal Device), OVE (Intervertebral Fusion Device With Integrated Fixation, Cervi), FMF (Syringe, Piston), HTR (Rasp)

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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