FDA 510(k) Application Details - K100614

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K100614
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	BLACKSTONE MEDICAL, INC. 1211 HAMBURG TURNPIKE SUITE 300 WAYNE, NJ 07470 US Other 510(k) Applications for this Company
Contact	DARLA CHEW Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2010
Decision Date	05/04/2010
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