aprevo® anterior lumbar interbody fusion device with interfixation— 510(k) K243635

Substantially Equivalent

Carlsmed, Inc.

FDA 510(k) clearance K243635 for aprevo® anterior lumbar interbody fusion device with interfixation, Substantially Equivalent on 2024-12-13. Applicant: Carlsmed, Inc..

Clearance details

Applicant: Carlsmed, Inc.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2024-11-25
Decision date: 2024-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.