Device Classification Name |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K111970 |
Device Name |
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
Applicant |
TORNIER
161 RUE LAVOISIER
MONTBONNOT
SAINT-ISMIER CEDEX 38334 FR
Other 510(k) Applications for this Company
|
Contact |
STEPHANIE BERNARD
Other 510(k) Applications for this Contact |
Regulation Number |
888.3540
More FDA Info for this Regulation Number |
Classification Product Code |
KRR
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/11/2011 |
Decision Date |
02/23/2012 |
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 |
|