Vantage PSI Tibia Cutting Guide
Vantage PSI Tibia Cutting Guide (351-80-10) is an osteotomy guide (FDA Class II; FDA product code OYK, Ankle Arthroplasty Implantation System) made by 3D Systems, Inc., cleared under FDA 510(k) K193432 on 9 Nov 2020 and listed in FDA GUDID since 13 Nov 2020 (UDI-DI 00816847022583), 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 | GUDID listing | Number00816847022583 | Date13 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK193432 | Date9 Nov 2020 | StatusActive |
Official records
- AccessGUDID record 00816847022583
- FDA 510(k) database K193432
Across registries
- FDA 510(k) K193432 decided 9 Nov 2020 Active
- FDA GUDID UDI-DI 00816847022583 listed 13 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K193432
- Listed FDA GUDID 00816847022583
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vantage PSI
- Generic name
- Osteotomy guide, single-use
- Model / Ref / Catalog
- Tibia Cutting Guide, 351-80-10
- Primary DI / UDI-DI
- 00816847022583
- 510(k) Number
- FDA product code
- OYK
- GMDN term
- Osteotomy guide, single-use
- Device class
- Class II
- Regulation number
- 888.3110
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe
- Size
- Length — 25 Millimeter
Similar devices
Other devices filed under FDA product code OYK (Ankle Arthroplasty Implantation System).