FDA 510(k) Application Details - K201585

Device Classification Name	More FDA Info for this Device
510(K) Number	K201585
Device Name	Monterey AL Interbody System
Applicant	Stryker Corporation 2 Pearl Court Allendale, NJ 07401 US Other 510(k) Applications for this Company
Contact	Alexia Haralambous Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/11/2020
Decision Date	08/10/2020
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