| Device Classification Name |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
| 510(K) Number |
K073120 |
| Device Name |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Applicant |
ACCELERATED INNOVATION, LLC
1033 US HIGHWAY 46 EAST
SUITE A204
CLIFTON, NJ 07013 US
Other 510(k) Applications for this Company
|
| Contact |
MICHAEL KVITNITSKY
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3540
More FDA Info for this Regulation Number |
| Classification Product Code |
KRR
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
11/05/2007 |
| Decision Date |
02/29/2008 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
OR - Orthopedic |
| Review Advisory Committee |
OR - Orthopedic |
| Statement / Summary / Purged Status |
Summary |
| Type |
Traditional |
| Reviewed By Third Party |
N |
| Expedited Review |
|