FDA 510(k) Application Details - K050764

Device Classification Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K050764
Device Name	Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Applicant	CORIN U.S.A. 10500 UNIVERSITY CENTER DR., SUITE 190 TAMPA, FL 33612 US Other 510(k) Applications for this Company
Contact	JOEL BATTS Other 510(k) Applications for this Contact
Regulation Number	888.3530   More FDA Info for this Regulation Number
Classification Product Code	HRY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/2005
Decision Date	08/24/2005
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