FDA 510(k) Application Details - K081163

Device Classification Name	Bone Cement, Antibiotic   More FDA Info for this Device
510(K) Number	K081163
Device Name	Bone Cement, Antibiotic
Applicant	DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DRIVE WARSAW, IN 46581-0988 US Other 510(k) Applications for this Company
Contact	SUZANA OTANO 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	04/24/2008
Decision Date	05/14/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review