FDA 510(k) Application Details - K162325

Device Classification Name	More FDA Info for this Device
510(K) Number	K162325
Device Name	Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
Applicant	Exactech Inc 2320 NW 66th Court Gainesville, FL 32653 US Other 510(k) Applications for this Company
Contact	Zach Sharrah 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	08/19/2016
Decision Date	03/06/2017
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review