K241332
- 510(k) number
- K241332
- Device name
- aprevo® anterior and lateral lumbar interbody fusion device; aprevo® anterior lumbar interbody fusion devices with interfixation; aprevo® transforaminal lumbar interbody fusion device
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-09-20
- Date received
- 2024-05-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 1.7 MB · U.S. public domain
Also available from FDA: K241332.pdf
Official FDA record: K241332
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.