FDA 510(k) Application Details - K211837

Device Classification Name	More FDA Info for this Device
510(K) Number	K211837
Device Name	Altus Spine Interbody Standalone Fusion System
Applicant	Altus Partners, LLC 1340 Enterprise Drive West Chester, PA 19380 US Other 510(k) Applications for this Company
Contact	Mark Melton 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	06/14/2021
Decision Date	04/19/2022
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