icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)— 510(k) K232792

Substantially Equivalent

Icotec AG

FDA 510(k) clearance K232792 for icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage), Substantially Equivalent on 2024-04-05. Applicant: Icotec AG.

Clearance details

Applicant: Icotec AG
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2023-09-11
Decision date: 2024-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 9450 Altstaetten (Sg), CH

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.