FDA 510(k) Application Details - K222936

Device Classification Name	More FDA Info for this Device
510(K) Number	K222936
Device Name	Humeris« 135 Shoulder System
Applicant	FX Shoulder USA, Inc. 13465 Midway Road Suite 101 Dallas, TX 75244 US Other 510(k) Applications for this Company
Contact	Cory Trier 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	09/26/2022
Decision Date	11/07/2022
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