FDA 510(k) Application Details - K191223

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K191223
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Blue Belt Technologies, Inc. 2905 Northwest Blvd., Ste. 40 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Amy Winegarden 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	05/07/2019
Decision Date	06/28/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review