FDA 510(k) Application Details - K121852

Device Classification Name	More FDA Info for this Device
510(K) Number	K121852
Device Name	SYNTHES ZERO-P VARIABLE ANGLE (VA)
Applicant	SYNTHES SPINE CO.LP 1302 WRIGHTS LANE EAST WEST CHESTER, PA 19380 US Other 510(k) Applications for this Company
Contact	MONIKA MCDOLE-RUSSELL Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/25/2012
Decision Date	07/25/2012
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