FDA 510(k) Application Details - K130302

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K130302
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SPINEVISION, S.A. ANTONY PARC II - 10 PLACE DU GENERAL DE GAULLE CS 70001 ANTONY CEDEX 92184 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	02/07/2013
Decision Date	07/30/2013
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