FDA 510(k) Application Details - K233191

Device Classification Name	More FDA Info for this Device
510(K) Number	K233191
Device Name	TotalTi ACDF by SAGICO
Applicant	Spinal Analytics & Geometrical Implant Co, LLC 2189 W Busch Blvd Tampa, FL 33612 US Other 510(k) Applications for this Company
Contact	James J. 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	09/28/2023
Decision Date	11/21/2023
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