FDA 510(k) Application Details - K182114

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Lumbar   More FDA Info for this Device
510(K) Number	K182114
Device Name	Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant	Integrity Implants Inc 850 Parkway Street Jupiter, FL 33477 US Other 510(k) Applications for this Company
Contact	Lauren Kamer Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	MAX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/06/2018
Decision Date	01/07/2019
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