FDA 510(k) Application Details - K212683

Device Classification Name	More FDA Info for this Device
510(K) Number	K212683
Device Name	GLOBAL ICON Stemless Shoulder System
Applicant	DePuy (Ireland) Loughbeg Ringaskiddy Co. Cork Munster IE Other 510(k) Applications for this Company
Contact	Kathy Harris Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PKC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/24/2021
Decision Date	01/19/2022
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