Company
Ossur Engineering, 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)
5recalls (0 in 12 months)
3recalls 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) |
|---|---|---|---|
| Mar 25, 2011 | Ossur Engineering, Inc Ossur Total Knee, Model Number: 2100
The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads. Terminated |
ISY | None listed |
| Sep 4, 2009 | Ossur Engineering, Inc Icelock Expulsion Valve 551 Model L-551000
The valve has a push button for suction release to release a lower limb prosthesis. Terminated |
ISP | None listed |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 510400D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 505400D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |
| Jun 19, 2009 | Ossur Engineering, Inc ReSolve Halo - Open Back Halo Ring, Model Number: 505300D
The ReSolve Halo Ring is a fixation device used to immobilize a patient with a cervical spine injury. Terminated |
HAX | K023959 K051918 |