FDA 510(k) Application Details - K072650

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K072650
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	INNOVATIVE SPINAL TECHNOLOGIES INC 111 FORBES BLVD. MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	GINA YEH 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	09/19/2007
Decision Date	11/28/2007
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