FDA 510(k) Application Details - K073303

Device Classification Name	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation   More FDA Info for this Device
510(K) Number	K073303
Device Name	Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
Applicant	SYNTHES (USA) 1230 WILSON DRIVE WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	JEFFREY L DOW Other 510(k) Applications for this Contact
Regulation Number	888.3045   More FDA Info for this Regulation Number
Classification Product Code	OIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2007
Decision Date	07/02/2008
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review