Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
More FDA Info for this Device |
510(K) Number |
K182535 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous |
Applicant |
Smith & Nephew, Inc.
7135 Goodlett Farms Parkway
Cordova, TN 38016 US
Other 510(k) Applications for this Company
|
Contact |
Meenakshi Gupta
Other 510(k) Applications for this Contact |
Regulation Number |
888.3358
More FDA Info for this Regulation Number |
Classification Product Code |
MBL
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/14/2018 |
Decision Date |
11/19/2018 |
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 |
|