FDA 510(k) Application Details - K213615

Device Classification Name	More FDA Info for this Device
510(K) Number	K213615
Device Name	Shoulder Innovations Total Shoulder System
Applicant	Shoulder Innovations, Inc. 13827 Port Sheldon Street Holland, MI 49424 US Other 510(k) Applications for this Company
Contact	Don Running 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	11/15/2021
Decision Date	03/11/2022
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