Device Dossier
Spinal cage
Device Dossier for Spinal cage (Spinal cage, Class IIb, sponsor Alphatec). ARTG record, intended purpose, GMDN category — compiled by arcimedes.
- GMDN category: Spinal cage
Intended purpose
The IdentiTi Standalone Interbody System is indicated for spinal fusion procedures in one or two contiguous levels in skeletally mature patients. IdentiTi ALIF Standalone Interbody System: For use in the lumbar spine (L2-S1) for the treatment of degenerative disc disease (DDD). The IdentiTi ALIF Standalone Interbody System implants of ≤20° are a standalone system. The IdentiTi ALIF Standalone Interbody System implants of >20° must be used with supplemental spinal fixation systems for use in the lumbar spine in addition to the integrated screws. IdentiTi Cervical Standalone Interbody System: is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at levels (C2-T1). The IdentiTi Cervical Standalone Interbody System is intended to be used with the bone screw fixation provided andRequires no additional fixation.