Carlsmed, Inc. · Class II · Cleared Dec 22, 2025
| K-number | K252611 |
| Device name | aprevo® cervical plating system |
| Applicant | Carlsmed, Inc. |
| Product code | KWQ |
| Device class | Class II |
| Decision date | Dec 22, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 888.3060 |
The aprevo® cervical plating system is an anterior cervical spine fixation device consisting of segmental and multilevel titanium plates and fixation screws designed to treat degenerative disc disease, trauma, spondylolisthesis, spinal stenosis, deformities, tumors, pseudoarthrosis, and failed previous fusion at cervical levels C2-T1.
The device comprises additively manufactured titanium alloy (Ti-4Al-6V ELI) plates per ASTM F3001, titanium alloy fixation screws per ASTM F136, and stainless steel instruments per ASTM A564, all provided sterile for single-patient use. The system includes both segmental and multilevel plate configurations for cervical fixation.
ASTM F3001 (titanium plate manufacturing), ASTM F136 (titanium screw manufacturing), ASTM A564 (stainless steel instruments), and ASTM F1717 (static and dynamic compression bending and static torsion testing). Cadaveric evaluation was also performed.
The aprevo® cervical plating system is substantially equivalent to the Admiral ACP System (K212139) and other predicate devices based on identical intended use, operating principle, design, components, materials, biocompatibility, manufacturing, packaging, labeling, and sterility. Non-clinical testing demonstrated substantially equivalent mechanical performance to the predicates.
View the full FDA submission: accessdata.fda.gov