FDA.report

Facet joint prosthesis

Definition
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 intended to be fixed to the superior and inferior articulating surfaces of the joint. Fixation may be by means of a trans-laminar or trans-facet screw or bolt.
GUDID devices
17
Last updated
2026-03-17 18:52:00

Related Product Codes

CodeDeviceSpecialtyClassDevices
MRWSystem, Facet Screw Spinal DeviceUnknownU17

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00081013188039 ION AO Coupling Cannulated Handle SURGENTEC, LLCSR12-50062026-03-09
00810131880330T-Handle 3/16" ConnectionSURGENTEC, LLCSR11-50022026-03-09
00810131881252 6.5/7.0 Drill BitSURGENTEC, LLC SR12-64422026-03-09
00810131881788ION Cervical Disposable Instrument KitSURGENTEC, LLCTI-C-10002026-03-09
00810131881795ION Disposable Instrument KitSURGENTEC, LLCTI-K-10002026-03-09
00810131881832 7.5 Drill BitSURGENTEC, LLC SR12-64432026-03-09
00810131881856ION Metal Drill Guide - LargeSURGENTEC, LLC SR12-64082026-03-09
00810131881986 ION Caddy with Metal PlateSURGENTEC, LLC SR12-70242026-03-09
00810131882051 Facet Locator - LargeSURGENTEC, LLC SR12-64072026-03-09
00810131882068 Impactor LargeSURGENTEC, LLC SR12-64012026-03-09
00810131882075Serrated Rasp - LargeSURGENTEC, LLC SR12-64062026-03-09
00810131882174ION Large TraySURGENTEC, LLC SR12-70132026-03-09
00810131882402 6.0mm Drill BitSURGENTEC, LLC SR12-64412026-03-09
00810131882419Plastic Removal Sleeve - Standard - 7.0-7.5SURGENTEC, LLC SR12-64502026-03-09
00810131882426Plastic Removal Sleeve - Standard - 5.5-6.5SURGENTEC, LLC SR12-64492026-03-09
00810131882723ION Cervical TraySURGENTEC, LLC SR12-70112026-03-09
00810131882747ION Lumbar TraySURGENTEC, LLC SR12-70122026-03-09