GS Medical AnyPlus PEEK Cage System— 510(k) K200592

Substantially Equivalent

GS Medical Co., Ltd.

FDA 510(k) clearance K200592 for GS Medical AnyPlus PEEK Cage System, Substantially Equivalent on 2020-08-10. Applicant: GS Medical Co., Ltd..

Clearance details

Applicant
GS Medical Co., Ltd.
Product code
Code ODP
Advisory panel
Orthopedic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Osong-Eup, Cheongwon-Gun, KR
Download summary PDFView on FDA.gov ↗

Adverse events under product code ODP

product code ODP
Injury
310
Total
310

Source: openFDA MAUDE database, through . 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.