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

Name: FDA 510(k) clearance K130274
Creator: U.S. Food and Drug Administration
Published: 2013-10-29

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.. Device class: 2.

Clearance details

Applicant: Elite Surgical Supplies (Pty), Ltd.
Product code: Code MAX
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

Recent devices under product code MAX

view all

K261049 — SCALA® TL2026-08-20
K261430 — TruLift Expandable System2026-07-28
K253011 — Catalyft PL Expandable Interbody System2026-07-17
K261020 — Symmetrix L Spinal System2026-07-14
K253420 — Admiral ACP System +18 more2026-07-01

More clearances from Elite Surgical Supplies (Pty), Ltd.

view all

K200523 — Biolign® Roto-Loc Cervical Plate System2020-04-30
K080075 — MODIFICATION TO: VERTEFIX PEDICLE SCREW SPINAL SYSTEM2008-01-28
K063453 — VERTEFIX PEDICLE SCREW SPINAL SYSTEM2007-08-30

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.