FDA 510(k) Application Details - K974537

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K974537
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	SYNTHES (USA) P.O. BOX 1766 1690 RUSSELL ROAD PAOLI, PA 19301-1222 US Other 510(k) Applications for this Company
Contact	SHERI L MUSGNUNG Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/03/1997
Decision Date	02/18/1998
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