K243802
- 510(k) number
- K243802
- Device name
- aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2025-03-17
- Date received
- 2024-12-11
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243802.pdf
Official FDA record: K243802
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.