Company
Ossur North America Inc
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2013 | Ossur North America Inc Fixed Offset Adapter, A-642100.
The Offset Adapter is a fixed modular component which sets the tube 14.5 mm (0.57 inch) offset from the center line of the pyramid. It is made of a high-strength alloy Terminated |
ISH | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee 1900, Model Number TK 1900, external prosthetic knee. Terminated |
ISY | None listed |
| Jul 4, 2006 | Ossur North America Inc Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee. Terminated |
ISY | None listed |
| Jul 20, 2004 | Ossur North America Inc VSP Shock Module (as part of a prosthetic foot). Terminated |
ISH | None listed |
| May 14, 2003 | Ossur North America Inc Mauch XG, Caron Knee Frame.
Model numbers FDM01804U, FRM01804LU, FRM01851U, FRM61750. Terminated |
ISY | None listed |