FDA 510(k) Application Details - K131533

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K131533
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	K2M, INC. 751 MILLER DR., S.E., SUITE F1 Leesburg, VA 20175 US Other 510(k) Applications for this Company
Contact	NANCY GIEZEN Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/25/2013
Decision Date	11/09/2013
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