510(k) K260385— aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra cervical plating system

Substantially Equivalent

Carlsmed, Inc.

Clearance details

Applicant: Carlsmed, Inc.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2026-02-06
Decision date: 2026-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.