GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF)— 510(k) K111354

Substantially Equivalent

GS Medical Co., Ltd.

FDA 510(k) clearance K111354 for GS MEDICAL ANYPLUS PEEK LUMBAR CAGES (ALIF AND DLIF), Substantially Equivalent on 2011-10-17. Applicant: GS Medical Co., Ltd..

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code MAX
Advisory panel: Orthopedic
Date received: 2011-05-13
Decision date: 2011-10-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Douglassville, PA, US

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.