K252894
- 510(k) number
- K252894
- Device name
- aprevo® cervical interbody system
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2026-01-06
- Date received
- 2025-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K252894.pdf
Official FDA record: K252894
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.