FDA 510(k) Application Details - K092803

Device Classification Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K092803
Device Name	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	CARDO MEDICAL CORP. 1033 US HIGHWAY 46E SUITE A204 CLIFTON, NJ 07013 US Other 510(k) Applications for this Company
Contact	DENISE DUCHENE 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	09/11/2009
Decision Date	12/23/2009
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