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
IdentiTi Cervical Porous Ti Interbody System (including NanoTec ,and including IdentiTi SPS Interbody System) and IdentiTi II Cervical Interbody System: The IdentiTi Cervical Porous Ti Interbody System/IdentiTi II Cervical Interbody system is an anterior cervical interbody fusion system intended for spinal fusion procedures in skeletally mature patients at multiple contiguous levels from C2-T1. It is intended for use with supplemental fixation systems. The system is designed for use with autograft and allogeneic bone graft, or a bone void filler for use in intervertebral body fusion. IdentiTi Porous Ti lnterbody System (including NanoTec): The IdentiTi Porous Ti lnterbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients. AMP Anti-Migration Plate may be used with the IdentiTi LIF interbody spacers to provide integrated fixation. IdentiTi LIF spacers with >20° lordosis must be used with AMP Anti-Migration Plate in addition to supplemental fixation. IdentiTi ALIF interbody spacers with >20° lordosis must be used with an anterior plate as the form of supplemental fixation. Calibrate PSX Interbody System (including NanoTec): The Calibrate PSX Interbody System is indicated for spinal fusion procedures from L1 to S1 in skeletally mature patients at one or two adjacent levels. Additionally, the system can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Calibrate LTX Interbody System: The Calibrate LTX Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients at one or two adjacent levels. Additionally, the system can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. Calibrate LTX spacers expanded greater than 20° must be used with the provided bone screws in addition to supplemental fixation. Calibrate LTX spacers without integrated fixation features may be used with AMP-LTX Anti-Migration Plate as integrated fixation in addition to supplemental fixation. The IdentiTi Porous Ti lnterbody System is intended to be used with autograft and/or allogeneic bone graft or a bone void filler for use in intervertebral body fusion, and can also be used with supplemental fixation systems. Calibrate PSX Interbody System and Calibrate LTX Interbody System are intended to be used with autograft and/or allogeneic bone graft and can also be used with supplemental fixation systems. IdentiTi II Interbody System: The IdentiTi II Interbody System is indicated for spinal fusion procedures from T1 to S1 in skeletally mature patients at one or two adjacent levels. It is intended to be used with autograft and/or allogenic bone graft or a bone void filler for use in intervertebral body fusion to facilitate fusion. When used with or without integrated fixation, the system is intended to be used with supplemental fixation systems for use in the thoracic and lumbar spine. AMP™ II Anti-Migration Plate may be used with IdentiTi II LIF interbody spacers to provide integrated fixation. IdentiTi II LIF spacers with >20° lordosis must be used with AMP II Anti Migration Plate in addition to supplemental fixation.