FDA 510(k) Application Details - K090477

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K090477
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SANACOR PO BOX 1196 PLEASANT GROVE, UT 84062 US Other 510(k) Applications for this Company
Contact	MICHAEL ENSIGN Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/24/2009
Decision Date	07/27/2009
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