Vy Spine, LLC · Class II · Cleared Mar 27, 2026
| K-number | K260697 |
| Device name | VyPlate Anterior Cervical Plate System |
| Applicant | Vy Spine, LLC |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The VyPlate™ Anterior Cervical Plate System is an anterior cervical plate with integrated cover plates and bone screws made of titanium alloy (6Al-4V). It is indicated for stabilization of the cervical spine from C2 to C7 using unicortical screw fixation in cases of trauma, deformity, pseudoarthosis, tumor reconstruction, and degenerative disk disease.
The device consists of implant, instrument, and tray components composed of titanium alloy 6Al-4V per ASTM F-136. The subject device has the same material, design, sizes, and biocompatibility as the predicate device but will be sold as a gamma-irradiated sterile packaged product. The device contains no software or electrical equipment.
ASTM F1717 Standards (non-clinical testing for mechanical properties); ASTM F-136 (titanium alloy material specification).
The VyPlate™ Anterior Cervical Plate System (K260697) is substantially equivalent to its predicate K221572 based on identical material composition, design, sizes, intended use, levels of attachment, and strength. Both devices underwent equivalent non-clinical testing, and the only modification is the addition of gamma irradiation sterilization and sterile packaging.
View the full FDA submission: accessdata.fda.gov