FDA 510(k) Application Details - K092150

Device Classification Name	Bone Cement   More FDA Info for this Device
510(K) Number	K092150
Device Name	Bone Cement
Applicant	BIOMET, INC. 56 EAST BELL DR. BOX 587 WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	SUSAN ALEXANDER Other 510(k) Applications for this Contact
Regulation Number	888.3027   More FDA Info for this Regulation Number
Classification Product Code	LOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/16/2009
Decision Date	10/27/2009
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