FDA 510(k) Application Details - K180523

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K180523
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Intai Technology Corporation No. 9 Jingke Rd., Nantun Dist., Taichung City 40852 TW Other 510(k) Applications for this Company
Contact	Shih-Chang Chuang 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	02/27/2018
Decision Date	09/20/2019
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