FDA 510(k) Application Details - K022615

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K022615
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	CENTERPULSE SPINE-TECH, INC. 7375 BUSH LAKE RD. MINNEAPOLIS, MN 55439-3037 US Other 510(k) Applications for this Company
Contact	ANGELA BYLAND Other 510(k) Applications for this Contact
Regulation Number	878.3300   More FDA Info for this Regulation Number
Classification Product Code	JDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/07/2002
Decision Date	10/29/2002
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review