FDA 510(k) Application Details - K070933

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K070933
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	SANACOR 765 EAST 340 SOUTH, SUITE 204 AMERICAN FORK, UT 84003 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	04/03/2007
Decision Date	06/13/2007
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