DOLOMITE Anterior Cervical Stabilization System— 510(k) K202065

Substantially Equivalent

Astura Medical, LLC

FDA 510(k) clearance K202065 for DOLOMITE Anterior Cervical Stabilization System, Substantially Equivalent on 2020-10-26. Applicant: Astura Medical, LLC.

Clearance details

Applicant: Astura Medical, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2020-07-27
Decision date: 2020-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

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.