FDA 510(k) Application Details - K162531

Device Classification Name	More FDA Info for this Device
510(K) Number	K162531
Device Name	STERISPINE CC
Applicant	SAFE ORTHOPAEDICS PARC DES BELLEVUES ALLEE R. LUXEMBURG - BAT. CALIFORNIE ERAGNY SUR OISE 95610 FR Other 510(k) Applications for this Company
Contact	SOPHIE REHAULT Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/2016
Decision Date	12/29/2016
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