FDA 510(k) Application Details - K153629

Device Classification Name	More FDA Info for this Device
510(K) Number	K153629
Device Name	ArcadiusXP C Spinal System
Applicant	Aesculap Implant Systems, Inc. 3773 Corporate Parkway Center Valley, PA 18034 US Other 510(k) Applications for this Company
Contact	Lisa M Boyle 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	12/18/2015
Decision Date	05/25/2016
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