FDA 510(k) Application Details - K181435

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K181435
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Alphatec Spine, Inc. 5818 El Camino Real Carlsbad, CA 92008 US Other 510(k) Applications for this Company
Contact	Cynthia Adams 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	06/01/2018
Decision Date	08/21/2018
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