FDA 510(k) Application Details - K032078

Device Classification Name	Anchor, Suture, Bone Fixation, Metallic   More FDA Info for this Device
510(K) Number	K032078
Device Name	Anchor, Suture, Bone Fixation, Metallic
Applicant	MITEK WORLDWIDE A JOHNSON & JOHNSON COMPANY 249 VANDERBILT AVENUE NORWOOD, MA 02062 US Other 510(k) Applications for this Company
Contact	SERGIO J GADALETA Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	NOV Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2003
Decision Date	08/25/2003
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