FDA Product Code
FDA Product Code OYK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3110
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243173 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | Special | PDF ↗ |
| K243174 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-10-25 | Special | PDF ↗ |
| K241326 | Cadence Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K241148 | Salto Talaris Ankle PSI System | 3D Systems, Inc. | 2024-08-30 | Traditional | PDF ↗ |
| K231585 | Vantage PSI System | 3D Systems, Inc. | 2023-06-30 | Special | PDF ↗ |
| K223326 | Axiom PSR System | Restor3D | 2023-03-30 | Traditional | PDF ↗ |
| K193432 | Vantage PSI System | 3D Systems | 2020-11-09 | Traditional | PDF ↗ |
Product code OYK · Class II · Orthopedic. Data: openFDA.