Device Classification Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
More FDA Info for this Device |
510(K) Number |
K101433 |
Device Name |
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive |
Applicant |
DEPUY ORTHOPAEDICS, INC.
700 ORTHOPAEDIC DRIVE
WARSAW, IN 46581-0988 US
Other 510(k) Applications for this Company
|
Contact |
KATHY BOGGS
Other 510(k) Applications for this Contact |
Regulation Number |
888.3560
More FDA Info for this Regulation Number |
Classification Product Code |
OIY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
05/21/2010 |
Decision Date |
12/10/2010 |
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 |
|