FDA 510(k) Application Details - K173175

Device Classification Name	More FDA Info for this Device
510(K) Number	K173175
Device Name	Paramount Anterior Cervical Cage System
Applicant	Spine Wave, Inc. 3 Enterprise Drive Suite 210 Shelton, CT 06484 US Other 510(k) Applications for this Company
Contact	Yvonne Riley-Poku 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	09/29/2017
Decision Date	11/01/2017
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