FDA 510(k) Application Details - K111048

Device Classification Name	Vessel Guard Or Cover   More FDA Info for this Device
510(K) Number	K111048
Device Name	Vessel Guard Or Cover
Applicant	SYNTHES SPINE 1302 WRIGHTS LN EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	HEATHER GUERIN Other 510(k) Applications for this Contact
Regulation Number	870.3470   More FDA Info for this Regulation Number
Classification Product Code	OMR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/15/2011
Decision Date	06/14/2012
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review