FDA 510(k) Application Details - K241097

Device Classification Name	More FDA Info for this Device
510(K) Number	K241097
Device Name	Arthrex Virtual Implant Positioning (VIP) System Software
Applicant	Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 US Other 510(k) Applications for this Company
Contact	Troy Brooks Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/22/2024
Decision Date	10/02/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review