FDA 510(k) Application Details - K240278

Device Classification Name	More FDA Info for this Device
510(K) Number	K240278
Device Name	Full Wedge Lateralized and Augmented Baseplates
Applicant	FX Shoulder USA, Inc. 15920 Addison Road, Suite 200 Addison, TX 75001 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	02/01/2024
Decision Date	05/15/2024
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