FDA 510(k) Application Details - K231593

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K231593
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Spinal Elements, Inc 3115 Melrose Dr., Suite 200 Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Julie Lamothe Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2023
Decision Date	08/02/2023
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