FDA 510(k) Application Details - K123164

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K123164
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FREDY H VARELA Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2012
Decision Date	02/15/2013
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