FDA 510(k) Application Details - K223143

Device Classification Name	More FDA Info for this Device
510(K) Number	K223143
Device Name	SAGICO Spinal System
Applicant	Sagico VA USA, LLC 2189 W.Busch Blvd Tampa, FL 33612 US Other 510(k) Applications for this Company
Contact	James G Gibson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/04/2022
Decision Date	06/26/2023
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