K243635
- 510(k) number
- K243635
- Device name
- aprevo® anterior lumbar interbody fusion device with interfixation
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- OVD — Intervertebral Fusion Device With Integrated Fixatio
- Decision date
- 2024-12-13
- Date received
- 2024-11-25
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243635.pdf
Official FDA record: K243635
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.