FDA 510(k) Application Details - K051971

Device Classification Name	Appliance, Fixation, Spinal Intervertebral Body   More FDA Info for this Device
510(K) Number	K051971
Device Name	Appliance, Fixation, Spinal Intervertebral Body
Applicant	U&I CORP. 529-1 YONGHYUN-DONG EUIJUNGBU, KYUNGGI-DO 480-050 KR Other 510(k) Applications for this Company
Contact	BETTY LIM Other 510(k) Applications for this Contact
Regulation Number	888.3060   More FDA Info for this Regulation Number
Classification Product Code	KWQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/21/2005
Decision Date	08/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review