FDA 510(k) Application Details - K243386

Device Classification Name	More FDA Info for this Device
510(K) Number	K243386
Device Name	Ventris Intervertebral Body Fusion Device
Applicant	Acuity Surgical Devices LLC 8710 N Royal Lane Irving, TX 75063 US Other 510(k) Applications for this Company
Contact	Chuck Forton Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/31/2024
Decision Date	04/22/2025
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