FDA 510(k) Application Details - K053488

Device Classification Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K053488
Device Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	CONFORMIS, INC. 323 VINTAGE PARK DR. SUITE C FOSTER CITY, CA 94404 US Other 510(k) Applications for this Company
Contact	PATRICK HESS Other 510(k) Applications for this Contact
Regulation Number	888.3560   More FDA Info for this Regulation Number
Classification Product Code	NPJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2005
Decision Date	03/09/2006
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