FDA 510(k) Application Details - K231445

Device Classification Name	More FDA Info for this Device
510(K) Number	K231445
Device Name	LINK Embrace Shoulder System - Reverse Configuration
Applicant	Waldemar Link GmbH & Co. KG Barkhausenweg 10 Hamburg 22339 DE Other 510(k) Applications for this Company
Contact	Stefanie 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	05/18/2023
Decision Date	11/16/2023
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