FDA 510(k) Application Details - K210790

Device Classification Name	More FDA Info for this Device
510(K) Number	K210790
Device Name	Lateralized and Augmented Baseplates
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	03/16/2021
Decision Date	08/25/2021
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