FDA 510(k) Application Details - K243980

Device Classification Name	More FDA Info for this Device
510(K) Number	K243980
Device Name	ARVIS Surgical Navigation System
Applicant	Kico Knee Innovation Company Pty Limited Unit 1, 25 Frenchs Forest Rd E Frenchs Forest 2086 AU Other 510(k) Applications for this Company
Contact	Ryan Matthew Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	SBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	03/21/2025
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