FDA 510(k) Application Details - K093464

Device Classification Name	Screw, Fixation, Intraosseous   More FDA Info for this Device
510(K) Number	K093464
Device Name	Screw, Fixation, Intraosseous
Applicant	SYNTHES (USA) 1230 WILSON DRIVE WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	SUSAN LEWANDOWSKI Other 510(k) Applications for this Contact
Regulation Number	872.4880   More FDA Info for this Regulation Number
Classification Product Code	DZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/06/2009
Decision Date	01/25/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review