FDA 510(k) Application Details - K033508

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K033508
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	SPINEVISION, INC. 3003 SUMMIT BLVD. SUITE 1400 ATLANTA, GA 30319 US Other 510(k) Applications for this Company
Contact	LYNNETTE WHITAKER 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	11/06/2003
Decision Date	01/27/2004
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