FDA 510(k) Application Details - K213876

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K213876
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Spineology Inc. 7800 3rd Street North, Suite 600 Saint Paul, MN 55128 US Other 510(k) Applications for this Company
Contact	Andrew Adams 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	12/13/2021
Decision Date	08/05/2022
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