SCARLET® AC-T Secured Anterior Cervical Cage— 510(k) K143214

Substantially Equivalent

Spineart

FDA 510(k) clearance K143214 for SCARLET® AC-T Secured Anterior Cervical Cage, Substantially Equivalent on 2015-02-23. Applicant: Spineart.

Clearance details

Applicant: Spineart
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2014-11-10
Decision date: 2015-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geneva, CH

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.