Device Classification Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
More FDA Info for this Device |
510(K) Number |
K130652 |
Device Name |
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
Applicant |
CONSENSUS ORTHOPEDICS, INC.
1115 WINDFIELD WAY STE 100
EL DORADO HILLS, CA 95762 US
Other 510(k) Applications for this Company
|
Contact |
MATTHEW HULL
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 |
03/12/2013 |
Decision Date |
12/17/2013 |
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 |
|