FDA 510(k) Application Details - K011443

Device Classification Name	Prosthesis, Hip, Cement Restrictor   More FDA Info for this Device
510(K) Number	K011443
Device Name	Prosthesis, Hip, Cement Restrictor
Applicant	MEDTRONIC SOFAMOR DANEK USA, INC. 1800 PYRAMID PLACE MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	RICHARD TREHARNE 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	05/11/2001
Decision Date	08/03/2001
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review