FDA 510(k) Application Details - K040947

Device Classification Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented   More FDA Info for this Device
510(K) Number	K040947
Device Name	Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Applicant	CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. AUSTIN, TX 78717 US Other 510(k) Applications for this Company
Contact	AUDREY SWEARINGEN Other 510(k) Applications for this Contact
Regulation Number	888.3390   More FDA Info for this Regulation Number
Classification Product Code	KWY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2004
Decision Date	08/27/2004
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