Submission Details
| 510(k) Number | K252611 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 18, 2025 |
| Decision Date | December 22, 2025 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
aprevo? cervical plating system
Dec 2025
Decision
126d
Days
Class 2
Risk
About This 510(k) Submission
K252611 is an FDA 510(k) clearance for the aprevo? cervical plating system, a Appliance, Fixation, Spinal Intervertebral Body (Class II — Special Controls, product code KWQ), submitted by Carlsmed, Inc. (Carlsbad, US). The FDA issued a Cleared decision on December 22, 2025, 126 days after receiving the submission on August 18, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3060.
Device Classification
| Product Code | KWQ — Appliance, Fixation, Spinal Intervertebral Body |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3060 |
Manufacturer
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