FDA 510(k) Application Details - K213117

Device Classification Name	More FDA Info for this Device
510(K) Number	K213117
Device Name	FX V135 Shoulder Prosthesis
Applicant	FX Shoulder USA, Inc. 13465 Midway Road, Suite 101 Dallas, TX 75244 US Other 510(k) Applications for this Company
Contact	Kathy 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	09/27/2021
Decision Date	06/07/2022
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