FDA 510(k) Application Details - K160982

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K160982
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	Eden Spine LLC 377 Maitland Avenue, SUite 1015 Atlamonte Springs, FL 32701 US Other 510(k) Applications for this Company
Contact	Guillaume Viallaneix Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/2016
Decision Date	12/22/2016
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