| Device Classification Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
| 510(K) Number |
K073248 |
| Device Name |
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Applicant |
MAKO SURGICAL CORP.
2555 DAVIE RD., SUITE 110
FT. LAUDERDALE, FL 33317 US
Other 510(k) Applications for this Company
|
| Contact |
WILLIAM F TAPIA
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3520
More FDA Info for this Regulation Number |
| Classification Product Code |
HSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
11/19/2007 |
| Decision Date |
12/12/2007 |
| Decision |
SESE - SUBST EQUIV |
| Classification Advisory Committee |
OR - Orthopedic |
| Review Advisory Committee |
OR - Orthopedic |
| Statement / Summary / Purged Status |
Summary |
| Type |
Special |
| Reviewed By Third Party |
N |
| Expedited Review |
|