FDA 510(k) Application Details - K003504

Device Classification Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K003504
Device Name	Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Applicant	PLUS ORTHOPEDICS 3550 GENERAL ATOMICS CT. BLDG. #15-100 SAN DIEGO, CA 92121-1194 US Other 510(k) Applications for this Company
Contact	HARMTMUT LOCH Other 510(k) Applications for this Contact
Regulation Number	888.3510   More FDA Info for this Regulation Number
Classification Product Code	KRO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/13/2000
Decision Date	05/11/2001
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