| K-number | K243369 |
| Device name | Cervical Plating System |
| Applicant | Life Spine, Inc. |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Dec 11, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The Cervical Plating System is an anterior cervical spine fixation device consisting of titanium alloy plates and screws used to temporarily stabilize the spine from C2 to T1 during fusion procedures. It treats degenerative disc disease, spondylolisthesis, trauma, stenosis, deformity, tumors, pseudarthrosis, and failed previous fusions; when used with a Life Spine cervical interbody, it is limited to degenerative disc disease treatment only.
The device is manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136, the same material as the predicate devices. It comprises plates, screws, and associated instruments for bone screw fixation through an anterior approach. All components are single-use only and must not be mixed with stainless steel or components from other manufacturers.
Dynamic and static testing per ASTM F1717, which covers axial compression, bending, and static torsion performance evaluation of spinal fixation devices.
The Cervical Plating System is substantially equivalent because it shares identical indications for use, design function, material composition (titanium alloy ASTM F136), and mechanical performance characteristics with the predicate devices Life Spine GRUVE and Neo-UL. Testing demonstrated equivalent performance in axial compression, bending, and torsion per the applicable consensus standard, confirming functional equivalence despite being a different product iteration from Life Spine.
View the full FDA submission: accessdata.fda.gov