FDA 510(k) Application Details - K083338

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K083338
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	ETHEL BERNAL 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	11/12/2008
Decision Date	02/02/2009
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