Southern Anterior Screw Fixated Cage (SASCA)— 510(k) K221447

Substantially Equivalent

Southern Medical (Pty) , Ltd.

FDA 510(k) clearance K221447 for Southern Anterior Screw Fixated Cage (SASCA), Substantially Equivalent on 2022-10-14. Applicant: Southern Medical (Pty) , Ltd..

Clearance details

Applicant: Southern Medical (Pty) , Ltd.
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2022-05-18
Decision date: 2022-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irene, ZA

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.