FDA 510(k) Application Details - K163428

Device Classification Name	More FDA Info for this Device
510(K) Number	K163428
Device Name	HA Minuteman G3-R MIS Fusion Plate
Applicant	Spinal Simplicity 10995 Quivira Road Overland Park, KS 66210 US Other 510(k) Applications for this Company
Contact	Douglas B Snell Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/06/2016
Decision Date	02/02/2017
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