FDA 510(k) Application Details - K240062

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K240062
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Insight Medical Systems, Inc. 9801 Metric Blvd Suite 200 Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Matthew Ryan 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	01/09/2024
Decision Date	04/29/2024
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