FDA 510(k) Application Details - K191146

Device Classification Name	More FDA Info for this Device
510(K) Number	K191146
Device Name	Humelock TiN Coated Glenosphere
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	04/30/2019
Decision Date	07/15/2020
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