FDA 510(k) Application Details - K241783

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K241783
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Vy Spine, LLC 545 W 500 South Suite 100 Bountiful, UT 84010 US Other 510(k) Applications for this Company
Contact	Jordan Hendrickson Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2024
Decision Date	03/18/2025
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