FDA 510(k) Application Details - K061144

Device Classification Name	Bone Cement, Antibiotic   More FDA Info for this Device
510(K) Number	K061144
Device Name	Bone Cement, Antibiotic
Applicant	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. P.O. BOX 988 WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	NATALIE S HECK Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	MBB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2006
Decision Date	06/08/2006
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