K260385
- 510(k) number
- K260385
- Device name
- aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
- Decision date
- 2026-05-09
- Date received
- 2026-02-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Orthopedic
PDFDownload 510(k) SummaryArchived here · 3.9 MB · U.S. public domain
Also available from FDA: K260385.pdf
Official FDA record: K260385
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.