FDA 510(k) Application Details - K122163

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K122163
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 US Other 510(k) Applications for this Company
Contact	DAVID KIRSCHMAN 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	07/20/2012
Decision Date	10/31/2012
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