Device Classification Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
More FDA Info for this Device |
510(K) Number |
K163081 |
Device Name |
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
Applicant |
SIGNATURE ORTHOPAEDICS PTY LTD.
7 SIRIUS ROAD
LANE COVE 2066 AU
Other 510(k) Applications for this Company
|
Contact |
Declan Brazil
Other 510(k) Applications for this Contact |
Regulation Number |
888.3390
More FDA Info for this Regulation Number |
Classification Product Code |
KWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
11/03/2016 |
Decision Date |
01/29/2018 |
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 |
|