FDA 510(k) Application Details - K243950

Device Classification Name	More FDA Info for this Device
510(K) Number	K243950
Device Name	ARVIS« Shoulder
Applicant	Kico Knee Innovation Company Pty Ltd 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	01/13/2025
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