Device Classification Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
More FDA Info for this Device |
510(K) Number |
K051510 |
Device Name |
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
Applicant |
SIGNAL MEDICAL CORP.
400 PYRAMID DR.
MARYSVILLE, MI 48040 US
Other 510(k) Applications for this Company
|
Contact |
LOUIS A SERAFIN
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 |
06/07/2005 |
Decision Date |
03/22/2006 |
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 |
|