Vantage PSI System
FDA 510(k) clearance K231585 · decided 2023-06-30
Clearance details
- K-number
- K231585
- Device name
- Vantage PSI System
- Applicant
- 3D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-05-31
- Decision date
- 2023-06-30
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- OYK
- Device class
- 2
- Regulation number
- 888.3110
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Littleton, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Salto Talaris Ankle PSI System (K243173) | 3D Systems, Inc. | 2024-10-25 |
| Cadence Ankle PSI System (K243174) | 3D Systems, Inc. | 2024-10-25 |
| Salto Talaris Ankle PSI System (K241148) | 3D Systems, Inc. | 2024-08-30 |
| Cadence Ankle PSI System (K241326) | 3D Systems, Inc. | 2024-08-30 |
| Axiom PSR System (K223326) | Restor3D | 2023-03-30 |
| Vantage PSI System (K193432) | 3D Systems | 2020-11-09 |
Recalls involving this device
No recalls on record reference this clearance.