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

Name: FDA 510(k) clearance K153517
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

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.. Device class: 2.

Clearance details

Applicant: GS Medical Co., Ltd.
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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K254130 — C.A. Medical Interbody Fusion System2026-07-08

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K240350 — AnyPlus II Spinal Fixation System2024-04-03
K231808 — QUASAR Standalone ACIF System2023-07-20
K223868 — PYXIS 3D Titanium Cage System2023-04-26

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.