FDA 510(k) Application Details - K083089

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K083089
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
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	888.3070   More FDA Info for this Regulation Number
Classification Product Code	NKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/16/2008
Decision Date	01/13/2009
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review