FDA 510(k) Application Details - K212415

Device Classification Name	More FDA Info for this Device
510(K) Number	K212415
Device Name	Arthrex Modular Glenoid System-Titanium Glenosphere
Applicant	Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 US Other 510(k) Applications for this Company
Contact	David L. Rogers 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	08/03/2021
Decision Date	11/17/2021
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