K250987

aprevo® posterior/transforaminal lumbar interbody fusion device

510(k) number: K250987
Device name: aprevo® posterior/transforaminal lumbar interbody fusion device
Applicant: Carlsmed, Inc. CA · US
Product code: MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Decision date: 2025-06-30
Date received: 2025-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Orthopedic

Also available from FDA: K250987.pdf

Official FDA record: K250987

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.