FDA 510(k) Application Details - K232619

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K232619
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Sapphire Medical Group 32565B Golden Lantern Street Suite 113 Dana Point, CA 92629 US Other 510(k) Applications for this Company
Contact	Anthony Ruggiero Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2023
Decision Date	03/19/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review