Vantage PSI System
by 3D Systems
510(k) K193432
Vantage PSI System is a medical device (FDA Class II; FDA product code OYK, Ankle Arthroplasty Implantation System) made by 3D Systems, cleared under FDA 510(k) K193432 on 9 Nov 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK193432 | Date9 Nov 2020 | StatusActive |
Official records
- FDA 510(k) database K193432
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OYK
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3110
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K193432
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Vantage PSI Fluoroscopic Insert | 351-80-11 / Fluoroscopic Insert | 00816847022606 | Length 25 mm | On the market |
| Vantage PSI Talus Cutting Guide | 351-80-00 / Talus Cutting Guide | 00816847022576 | Length 25 mm | On the market |
| Vantage PSI Tibia Cutting Guide | 351-80-10 / Tibia Cutting Guide | 00816847022583 | Length 25 mm | On the market |
Similar devices
Other devices filed under FDA product code OYK (Ankle Arthroplasty Implantation System).