FDA 510(k) Application Details - K112206

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K112206
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	SEASPINE, INC. 2302 LA MIRADA DR. VISTA, CA 92081-7862 US Other 510(k) Applications for this Company
Contact	DAN MILLER 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	08/01/2011
Decision Date	01/25/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review