FDA.reportPublic FDA data

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
63
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
M719GCV05LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV05LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV05SL0Apache Genesys Orthopedics Systems LLC12016-09-29
M719GCV05SP0Apache Genesys Orthopedics Systems LLC12016-09-29
M719GCV06LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV06LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV06LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV06SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV06SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV06SP0Apache Genesys Orthopedics Systems LLC12016-09-29
M719GCV07LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV07LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV07LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV07SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV07SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV07SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV08LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV08LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV08LP0ApacheGenesys Orthopedics Systems LLC22016-09-29
M719GCV08SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV08SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV08SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV09LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV09LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV09LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV09SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV09SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV09SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV10LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV10LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV10LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV10SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV10SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV10SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV11LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV11LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV11LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV11SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV11SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV11SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV12LC0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV12LL0ApacheGenesys Orthopedics Systems LLC12016-09-30
M719GCV12LP0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV12SC0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV12SL0ApacheGenesys Orthopedics Systems LLC12016-09-29
M719GCV12SP0ApacheGenesys Orthopedics Systems LLC12016-09-29
00081013188039 ION AO Coupling Cannulated Handle Surgentec, LLCSR12-50062026-03-09
00810131880330"T-Handle 3/16"" Connection"Surgentec, 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