FDA 510(k) Application Details - K160124

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K160124
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SpineVision S.A. 10 rue de la Renaissance, Batiment E Antony 92160 FR Other 510(k) Applications for this Company
Contact	Helene Plas Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/20/2016
Decision Date	04/04/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review