Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
More FDA Info for this Device |
510(K) Number |
K140130 |
Device Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Applicant |
ENCORE MEDICAL, L.P.
9800 METRIC BLVD.
AUSTIN, TX 78758 US
Other 510(k) Applications for this Company
|
Contact |
TEFFANY HUTTO
Other 510(k) Applications for this Contact |
Regulation Number |
888.3358
More FDA Info for this Regulation Number |
Classification Product Code |
OQG
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/17/2014 |
Decision Date |
11/06/2014 |
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 |
|