FDA 510(k) Application Details - K090549

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K090549
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	SYNTHES SPINE 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	STACEY BONNELL 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	03/02/2009
Decision Date	05/21/2009
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