FDA 510(k) Application Details - K042928

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K042928
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
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	888.3070   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	10/22/2004
Decision Date	02/17/2005
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