FDA 510(k) Application Details - K200895

Device Classification Name	More FDA Info for this Device
510(K) Number	K200895
Device Name	Univers Revers Modular Glenoid System, Half Augment Baseplate
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 US Other 510(k) Applications for this Company
Contact	Ivette Galmez Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/03/2020
Decision Date	08/13/2020
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