Southern Transforaminal Lumbar Interbody Fusion (TLIF)— 510(k) K221182

Substantially Equivalent

Southern Medical (Pty) , Ltd.

FDA 510(k) clearance K221182 for Southern Transforaminal Lumbar Interbody Fusion (TLIF), Substantially Equivalent on 2022-12-08. Applicant: Southern Medical (Pty) , Ltd..

Clearance details

Applicant: Southern Medical (Pty) , Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2022-04-25
Decision date: 2022-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irene, ZA

Download summary PDF View on FDA.gov ↗

Adverse events under product code MAX

product code MAX

Death: 13
Injury: 1,305
Malfunction: 2,885
Total: 4,203

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.