FDA 510(k) Application Details - K181606

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K181606
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 US Other 510(k) Applications for this Company
Contact	Michael C. Dawson 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	06/19/2018
Decision Date	09/27/2019
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