FDA 510(k) Application Details - K192316

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K192316
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Sapphire Medical Group 32565 B 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	08/26/2019
Decision Date	10/17/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review