FDA 510(k) Application Details - K161524

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K161524
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	NVISION BIOMEDICAL TECHNOLOGIES, LLC 1350 N LOOP 1604 E, SUITE 103 SAN ANTONIO, TX 78232 US Other 510(k) Applications for this Company
Contact	DIANA L. LANGHAM 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	06/02/2016
Decision Date	09/02/2016
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