FDA 510(k) Application Details - K133094

Device Classification Name	Appliance, Fixation, Spinal Interlaminal   More FDA Info for this Device
510(K) Number	K133094
Device Name	Appliance, Fixation, Spinal Interlaminal
Applicant	X-SPINE SYSTEMS, INC 452 Alexandersville Rd Miamisburg, OH 45342 US Other 510(k) Applications for this Company
Contact	DAVID KIRSCHMAN, M.D. Other 510(k) Applications for this Contact
Regulation Number	888.3050   More FDA Info for this Regulation Number
Classification Product Code	KWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2013
Decision Date	12/11/2013
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