SPICCA Stand-Alone Cervical Fusion Cages— 510(k) K230608

Substantially Equivalent

Southern Medical (Pty) , Ltd.

FDA 510(k) clearance K230608 for SPICCA Stand-Alone Cervical Fusion Cages, Substantially Equivalent on 2023-08-14. Applicant: Southern Medical (Pty) , Ltd..

Clearance details

Applicant: Southern Medical (Pty) , Ltd.
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2023-03-03
Decision date: 2023-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irene, ZA

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.