| Device Classification Name |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
| 510(K) Number |
K141740 |
| Device Name |
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Applicant |
WRIGHT MEDICAL TECHNOLOGY, INC.
1023 CHERRY ROAD
MEMPHIS, TN 38117 US
Other 510(k) Applications for this Company
|
| Contact |
JEANINE REDDEN
Other 510(k) Applications for this Contact |
| Regulation Number |
888.3110
More FDA Info for this Regulation Number |
| Classification Product Code |
HSN
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
| Date Received |
06/27/2014 |
| Decision Date |
03/05/2015 |
| 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 |
|