FDA 510(k) Application Details - K243802

Device Classification Name	More FDA Info for this Device
510(K) Number	K243802
Device Name	aprevo« anterior and lateral lumbar interbody fusion device, aprevo« anterior lumbar interbody fusion device with interfixation
Applicant	Carlsmed, Inc. 1800 Aston Ave., Ste. 100 Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Karen Liu 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	12/11/2024
Decision Date	03/17/2025
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