K242260
- 510(k) number
- K242260
- Device name
- aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- ODP — Intervertebral Fusion Device With Bone Graft, Cervic
- Decision date
- 2024-11-15
- Date received
- 2024-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K242260.pdf
Official FDA record: K242260
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.