Panels › Orthopedic › Product code OYK · Class 2
Ankle Arthroplasty Implantation System
Regulation 888.3110
0510(k)s in 12 months (7 all time)
1recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in OYK
| Company | 510(k)s | Recalls |
|---|---|---|
| 3D Systems | 6 | 0 |
| Restor3D | 1 | 1 |
| Integra LifeSciences Corp. | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 2024 | K243174 | Cadence Ankle PSI System 3D Systems, Inc. | OYK |
| Oct 25, 2024 | K243173 | Salto Talaris Ankle PSI System 3D Systems, Inc. | OYK |
| Aug 30, 2024 | K241326 | Cadence Ankle PSI System 3D Systems, Inc. | OYK |
| Aug 30, 2024 | K241148 | Salto Talaris Ankle PSI System 3D Systems, Inc. | OYK |
| Jun 30, 2023 | K231585 | Vantage PSI System 3D Systems, Inc. | OYK |
| Mar 30, 2023 | K223326 | Axiom PSR System Restor3D | OYK |
| Nov 9, 2020 | K193432 | Vantage PSI System 3D Systems | OYK |
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