K232282
- 510(k) number
- K232282
- Device name
- aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2024-03-22
- Date received
- 2023-07-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
510(k) Summary (official FDA PDF): K232282.pdf
Official FDA record: K232282
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.