FDA 510(k) Application Details - K080394

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K080394
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	WHITNEY G TORNING 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	02/13/2008
Decision Date	03/13/2008
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