Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K102927 |
Device Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Applicant |
Consensus Orthopedics, Inc
1115 WINFIELD WAY
SUITE 100
EL DORADO HILLS, CA 95762-9623 US
Other 510(k) Applications for this Company
|
Contact |
MATTHEW HULL
Other 510(k) Applications for this Contact |
Regulation Number |
888.3565
More FDA Info for this Regulation Number |
Classification Product Code |
MBH
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
10/04/2010 |
Decision Date |
01/26/2011 |
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 |
|