FDA 510(k) Application Details - K103671

Device Classification Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease   More FDA Info for this Device
510(K) Number	K103671
Device Name	Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Applicant	GENESYS SPINE 1250 CAPITAL OF TEXAS HWY SO. BUILDING THREE, SUITE 600 AUSTIN, TX 78746 US Other 510(k) Applications for this Company
Contact	BRIAN J BERGERON 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	12/16/2010
Decision Date	07/21/2011
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