FDA 510(k) Application Details - K233414

Device Classification Name	More FDA Info for this Device
510(K) Number	K233414
Device Name	Shoreline ACS Interbody System; Shoreline RT Interbody System
Applicant	SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Kendal Moulton 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	10/10/2023
Decision Date	11/28/2023
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