FDA 510(k) Application Details - K141791

Device Classification Name	More FDA Info for this Device
510(K) Number	K141791
Device Name	BIOMET FUSION SYSTEM
Applicant	BIOMET SPINE 310 INTERLOCKEN PARKWAY BROOMFIELD, CO 80021 US Other 510(k) Applications for this Company
Contact	TED KUHN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/02/2014
Decision Date	10/09/2014
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