FDA 510(k) Application Details - K051408

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K051408
Device Name	Staple, Fixation, Bone
Applicant	INTELIFUSE, INC. 5582 CHALON ROAD YORBA LINDA, CA 92886 US Other 510(k) Applications for this Company
Contact	SHARON ROCKWELL Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2005
Decision Date	06/29/2005
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