FDA 510(k) Application Details - K062670

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K062670
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	VERTIFLEX (TM), INCORPORATED 1954 KELLOGG AVENUE, SUITE 100 CARLSBAD, CA 92008 US Other 510(k) Applications for this Company
Contact	STEVE REITZLER 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	09/07/2006
Decision Date	01/12/2007
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