FDA 510(k) Application Details - K190415

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K190415
Device Name	Plate, Fixation, Bone
Applicant	MiRus, LLC 2150 Newmarket Parkway, Suite 108 Marietta, GA 30067 US Other 510(k) Applications for this Company
Contact	Jordan Bauman Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/21/2019
Decision Date	04/19/2019
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