FDA 510(k) Application Details - K063453

Device Classification Name	Orthosis, Spinal Pedicle Fixation   More FDA Info for this Device
510(K) Number	K063453
Device Name	Orthosis, Spinal Pedicle Fixation
Applicant	ELITE SURGICAL SUPPLIES (PTY) LTD. 503 COMMERCE PARK DRIVE SUITE I MARIETTA, GA 30060 US Other 510(k) Applications for this Company
Contact	CHARISE DE BARRIOS 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	11/15/2006
Decision Date	08/30/2007
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