FDA 510(k) Application Details - K122378

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K122378
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	BIOMET SPINE (AKA EBI, LLC) 100 INTERPACE PARKWAY PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	VIVIAN KELLY Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2012
Decision Date	09/20/2012
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