FDA 510(k) Application Details - K232572

Device Classification Name	Orthopedic Stereotaxic Instrument   More FDA Info for this Device
510(K) Number	K232572
Device Name	Orthopedic Stereotaxic Instrument
Applicant	Kalitec Direct, LLC doing business as Kalitec Medical 618 E. South Street Suite 500 Orlando, FL 32801 US Other 510(k) Applications for this Company
Contact	Winn Scott 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	08/24/2023
Decision Date	12/13/2023
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