FDA 510(k) Application Details - K191561

Device Classification Name	More FDA Info for this Device
510(K) Number	K191561
Device Name	Exactech Equinoxe Humeral Augmented Trays
Applicant	Exactech, Inc 2320 NW 66th Court Gainesville, FL 32653 US Other 510(k) Applications for this Company
Contact	Shing Jen Tai 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	06/13/2019
Decision Date	08/20/2019
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