FDA 510(k) Application Details - K094002

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K094002
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	SPARTEK MEDICAL, INC. 1100 MARINA VILLIAGE PKWY SUITE 103 ALAMEDA, CA 94501 US Other 510(k) Applications for this Company
Contact	HENRY KLYCE 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	12/28/2009
Decision Date	05/07/2010
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