FDA 510(k) Application Details - K161081

Device Classification Name	More FDA Info for this Device
510(K) Number	K161081
Device Name	SeaSpine Shoreline ACS - Anterior Cervical Standalone System
Applicant	SEASPINE ORTHOPEDICS CORPORATION 5770 ARMADA DRIVE CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	Michelle Willis 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	04/18/2016
Decision Date	09/14/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review