FDA 510(k) Application Details - K081568

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K081568
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	KIRSTEN STOWELL 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	06/04/2008
Decision Date	09/02/2008
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