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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2026 | restor3d Inc. Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 Open, Classified |
OYK | K223326 |
| Mar 2, 2012 | Integra LifeSciences Corp. Tibiaxys Ankle Arthrodesis Plate Compression Guide, Model #159635, part # 159 635, Batch #: EAHZ, EAJ1, ELGV, ENQE & ENQH.
Product Usage:
The Compression guide is a re-usable instrument used in the Terminated |
OYK | None listed |
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