FDA 510(k) Application Details - K182077

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K182077
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Mazor Robotics Ltd. 5 Shacham St. North Industrial Park Caesarea 3088900 IL Other 510(k) Applications for this Company
Contact	Marina Hefetz Other 510(k) Applications for this Contact
Regulation Number	882.4560   More FDA Info for this Regulation Number
Classification Product Code	OLO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/01/2018
Decision Date	11/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review