FDA 510(k) Application Details - K240716

Device Classification Name	More FDA Info for this Device
510(K) Number	K240716
Device Name	AETOS Shoulder System Stemless Humeral Prosthesis
Applicant	Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 US Other 510(k) Applications for this Company
Contact	Cassidy Whipple 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	03/15/2024
Decision Date	11/20/2024
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