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510(k) Data Aggregation
(236 days)
The SpinePoint Flex-Z™ Cervical Cage is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies) at multiple contiguous levels from C2-T1 spine using an anterior approach. The SpinePoint Flex-Z™ Cervical Cage is intended to be used with supplemental fixation systems and with allograft/allogenic bone graft, comprised of cancellous, cortical, and corticocancellous bone to facilitate fusion. Patients should receive 6 weeks of non-operative treatment prior to treatment with the SpinePoint Flex-Z™ Cervical Cage.
The SpinePoint Flex-Z™ Cervical Cage is an intervertebral body fusion device additively manufactured Grade 23 titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The device consists of lattice and a z-shaped frame to improve the stability of the spine while supporting fusion. Additional features include a graft window for packing bone graft and porous endplates to ensure placement is maintained after insertion and aid in osseointegration.
The Flex-Z™ Cervical Cage is available in multiple footprints, heights, and degrees of lordosis to accommodate patient anatomies and surgical approach. Implants are provided sterile in sterile packaging, are single-use only, and are intended to be used with FDA-cleared fixation devices such as an anterior cervical plate system.
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