FDA 510(k) Application Details - K042135

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K042135
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD PAOLI, PA 19301-1222 US Other 510(k) Applications for this Company
Contact	LISA M BOYLE Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/09/2004
Decision Date	10/07/2004
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