BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM— 510(k) K130274

Substantially Equivalent

Elite Surgical Supplies (Pty), Ltd.

FDA 510(k) clearance K130274 for BIOLIGN ACIF SYSTEMS, BIOLIGN STACC ACIF SYSTEM, BIOLIGN TLIF SYSTEM, Substantially Equivalent on 2013-10-29. Applicant: Elite Surgical Supplies (Pty), Ltd..

Clearance details

Applicant: Elite Surgical Supplies (Pty), Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2013-02-04
Decision date: 2013-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pretoria West Industrial, 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.