FDA 510(k) Application Details - K063423

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K063423
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	HOWMEDICA OSTEONICS 325 Corporate Drive Mahwah, NJ 07430 US Other 510(k) Applications for this Company
Contact	SHERYL R BAGALIO Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	JWH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2006
Decision Date	01/22/2007
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