aprevo® cervical interbody system— 510(k) K252894

Substantially Equivalent

Carlsmed, Inc.

FDA 510(k) clearance K252894 for aprevo® cervical interbody system, Substantially Equivalent on 2026-01-06. Applicant: Carlsmed, Inc..

Clearance details

Applicant: Carlsmed, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2025-09-11
Decision date: 2026-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.