FDA 510(k) Application Details - K001793

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite   More FDA Info for this Device
510(K) Number	K001793
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant	SYNTHES (USA) 1690 RUSSELL RD. PAOLI, PA 19301 US Other 510(k) Applications for this Company
Contact	ANGELA J SILVESTRI Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	LXT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/14/2000
Decision Date	08/17/2000
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