AnyPlus® Cervical PEEK Cage System— 510(k) K153517

Substantially Equivalent

GS Medical Co., Ltd.

FDA 510(k) clearance K153517 for AnyPlus® Cervical PEEK Cage System, Substantially Equivalent on 2016-06-24. Applicant: GS Medical Co., Ltd..

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2015-12-08
Decision date: 2016-06-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Osong-Eup, Cheongwon-Gun, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.