Device Classification Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device |
510(K) Number |
K121034 |
Device Name |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
Applicant |
ICONACY ORTHOPEDIC IMPLANTS, LLC
PO BOX 1033
WARSAW, IN 46581-1033 US
Other 510(k) Applications for this Company
|
Contact |
ROY Y HORI, PHD
Other 510(k) Applications for this Contact |
Regulation Number |
888.3358
More FDA Info for this Regulation Number |
Classification Product Code |
LPH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
04/05/2012 |
Decision Date |
09/04/2012 |
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 |
|