FDA 510(k) Application Details - K071668

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K071668
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	PARADIGM SPINE 505 PARK AVE. 14TH FLOOR NEW YORK, NY 10022 US Other 510(k) Applications for this Company
Contact	MARCI HALEVI Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/19/2007
Decision Date	07/02/2008
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