FDA 510(k) Application Details - K250827

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K250827
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Carlsmed, Inc. 1800 Aston Ave., Ste. 100 San Diego, CA 92008 US Other 510(k) Applications for this Company
Contact	Julie Lamothe 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	03/18/2025
Decision Date	07/07/2025
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