FDA 510(k) Application Details - K043058

Device Classification Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer   More FDA Info for this Device
510(K) Number	K043058
Device Name	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Applicant	DEPUY, INC. 700 ORTHOPAEDIC DR. WARSAW, IN 46582 US Other 510(k) Applications for this Company
Contact	Natalie Heck Other 510(k) Applications for this Contact
Regulation Number	888.3310   More FDA Info for this Regulation Number
Classification Product Code	KWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2004
Decision Date	03/14/2005
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