FDA 510(k) Application Details - K072866

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K072866
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	CUSTOM SPINE, INC. 1140 PARSIPPANY BLVD. SUITE 201 PARSIPPANY, NJ 07054 US Other 510(k) Applications for this Company
Contact	SAAD ATTIYAH 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	10/05/2007
Decision Date	12/13/2007
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