Panels › Physical Medicine › Product code ISY · Class 1
Joint, Knee, External Limb Component
Regulation 890.3420
0510(k)s in 12 months (1 all time)
0recalls in 12 months (17 all time)
0recalls that name a 510(k)
Top companies in ISY
| Company | 510(k)s | Recalls |
|---|---|---|
| Ossur North America Inc | 0 | 5 |
| Ottobock Orthopedic Industrie | 0 | 3 |
| Otto Bock Healthcare GmbH | 0 | 2 |
| Otto Bock Healthcare Product | 0 | 2 |
| Bock,Otto,Orthopedic Ind,Inc | 0 | 1 |
| Medi Manufacturing Inc | 0 | 1 |
| Ossur | 0 | 1 |
| Ossur Engineering, Inc | 0 | 1 |
| Ossur H / F | 0 | 1 |
| Rizzoli Ortopedica S.P.A. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2010 | K101859 | REL-K ARTIFICAL LIMB PROSTHESIS Rizzoli Ortopedica S.P.A. | ISY |
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