FDA 510(k) Application Details - K251459

Device Classification Name	More FDA Info for this Device
510(K) Number	K251459
Device Name	OneLIFÖ Interbody Fusion System
Applicant	NovApproach Spine, LLC 13900 Tech City Circle Suite 300 Alachua, FL 32615 US Other 510(k) Applications for this Company
Contact	Ron Green 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	05/12/2025
Decision Date	06/12/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review