FDA 510(k) Application Details - K241992

Device Classification Name	More FDA Info for this Device
510(K) Number	K241992
Device Name	CatalyftÖ LS Expandable Interbody System
Applicant	Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 US Other 510(k) Applications for this Company
Contact	Rose Merlin Jose 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	07/08/2024
Decision Date	10/28/2024
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