Device Classification Name |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K161610 |
Device Name |
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
Applicant |
Encore Medical, L.P.
9800 METIRC BLVD
AUSTIN, TX 78758 US
Other 510(k) Applications for this Company
|
Contact |
TEFFANY HUTTO
Other 510(k) Applications for this Contact |
Regulation Number |
888.3310
More FDA Info for this Regulation Number |
Classification Product Code |
KWZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
06/10/2016 |
Decision Date |
11/09/2016 |
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 |
|