FDA 510(k) Application Details - K093513

Device Classification Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer   More FDA Info for this Device
510(K) Number	K093513
Device Name	Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Applicant	CONFORMIS, INC. 2 FOURTH AVENUE BURLINGTON, MA 01803 US Other 510(k) Applications for this Company
Contact	AMITA SHAH, RAC 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	11/13/2009
Decision Date	12/16/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review