| K-number | K252432 |
| Device name | Flex-Z Cervical Cage |
| Applicant | Spinepoint, LLC |
| Product code | ODP |
| Device class | Class II |
| Decision date | Mar 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3080 |
The Flex-Z™ Cervical Cage is an intervertebral body fusion device made of additively manufactured Grade 23 titanium alloy. It is indicated for use in skeletally mature patients with degenerative disc disease at multiple contiguous cervical spine levels (C2-T1) using an anterior surgical approach, in combination with supplemental fixation systems and bone graft to facilitate spinal fusion.
The device features a lattice and z-shaped frame design with a graft window for bone graft packing and porous endplates to aid osseointegration and maintain placement. It is available in multiple footprints, heights, and lordosis angles, provided sterile for single use, and is designed for use with FDA-cleared anterior cervical plate systems.
ASTM F2077-22 (Static Axial Compression, Static Compression Shear, Static Torsion, Dynamic Axial Compression, Dynamic Compression Shear, and Dynamic Torsion), ASTM F2267-24 (Subsidence and Expulsion), and ASTM F1798 (Taber Abrasion).
The Flex-Z™ Cervical Cage has identical or similar indications for use, similar technological characteristics, materials, surgical approach, and range of sizes as the predicate devices. Mechanical performance testing demonstrated the device achieves substantial equivalence to legally marketed predicate devices, with any design differences not raising different questions of safety or effectiveness.
View the full FDA submission: accessdata.fda.gov