FDA 510(k) Application Details - K200368

Device Classification Name	More FDA Info for this Device
510(K) Number	K200368
Device Name	LINK Embrace Shoulder System - Reverse Configuration
Applicant	Waldemar Link GmbH & Co. KG Ostsra▀e 4-10 Norderstedt 22844 DE Other 510(k) Applications for this Company
Contact	Stephanie Fuchs 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	02/14/2020
Decision Date	02/05/2021
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