FDA 510(k) Application Details - K200376

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K200376
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Navbit Pty Ltd Suite 1A, 136 Willoughby Road Crows Nest 2065 AU Other 510(k) Applications for this Company
Contact	David Thomson 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	02/18/2020
Decision Date	12/10/2020
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