FDA 510(k) Application Details - K180728

Device Classification Name	More FDA Info for this Device
510(K) Number	K180728
Device Name	Spinal Elements Cerclage System
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	More FDA Info for this Regulation Number
Classification Product Code	OWI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/20/2018
Decision Date	09/06/2018
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