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