FDA 510(k) Application Details - K223350

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K223350
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Fusion Robotics, LLC 168 Centennial Parkway Unit 170 Louisville, CO 80027 US Other 510(k) Applications for this Company
Contact	Sarah Braun 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	11/02/2022
Decision Date	03/13/2023
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