FDA 510(k) Application Details - K180401

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K180401
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	Kalitec Direct, LLC 618 E. South Street Suite 500 Orlando, FL 32801 US Other 510(k) Applications for this Company
Contact	Scott Winn 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	02/14/2018
Decision Date	06/14/2018
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