FDA 510(k) Application Details - K241961

Device Classification Name	More FDA Info for this Device
510(K) Number	K241961
Device Name	Vent Creativity Knee v1.0 (Hermes)
Applicant	Vent Creativity 101 6th Ave 3rd Floor New York, NY 10013 US Other 510(k) Applications for this Company
Contact	Craig Vittorio Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QIH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/2024
Decision Date	03/20/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review