FDA 510(k) Application Details - K053623

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K053623
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	N-SPINE, INC. P.O. BOX 560 STILLWATER, MN 55082 US Other 510(k) Applications for this Company
Contact	ELAINE DUNCAN 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	12/28/2005
Decision Date	07/12/2006
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