FDA 510(k) Application Details - K202098

Device Classification Name	More FDA Info for this Device
510(K) Number	K202098
Device Name	GLOBAL UNITEÖ Platform Shoulder System
Applicant	DePuy Ireland UC Loughbeg, Ringaskiddy Co. Cork Munster IE Other 510(k) Applications for this Company
Contact	Karen Mahoney 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	07/29/2020
Decision Date	11/25/2020
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