| K-number | K260570 |
| Device name | corra cervical plating system |
| Applicant | Carlsmed, Inc. |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Apr 22, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The corra™ cervical plating system is an anterior cervical spine fixation device comprising patient-specific segmental and multilevel plates additively manufactured from titanium alloy (Ti-4Al-6V ELI), along with titanium alloy screws and associated surgical instruments. It is intended for cervical fixation (C2-T1) for indications including degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, and failed previous fusion.
The corra™ cervical plating system technological characteristics are substantially equivalent to the predicate device, with comparison based on intended use, operating principle, design, components, materials, biocompatibility, manufacturing, labeling, and sterility. The system features patient-specific plates and multilevel configurations with plates per ASTM F3001 and screws per ASTM F136.
Dynamic compression shear testing was performed in accordance with ASTM F2077 to evaluate the updated design feature of the corra™ cervical plating system.
The submitted data demonstrates substantial equivalence based on comparison of intended use/indications for use, technological characteristics (operating principle, design, components, materials, biocompatibility, manufacturing, labeling, sterility), and non-clinical testing results. The device is substantially equivalent to the predicate aprevo® cervical plating system (K252611), which shares the same product code, intended use, and material composition.
View the full FDA submission: accessdata.fda.gov