FDA 510(k) Application Details - K053573

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K053573
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	GS MEDICAL CO., LTD. 222-13 GURO-DONG, GURO-GU ROOM NO. 703 SEOUL 152-848 KR Other 510(k) Applications for this Company
Contact	SUN-EUN JUNG 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	12/22/2005
Decision Date	03/08/2006
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