FDA 510(k) Application Details - K963432

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite   More FDA Info for this Device
510(K) Number	K963432
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Applicant	ORTHOPAEDIC BIOSYSTEMS, LTD. 7320 EAST BUTHERUS SUITE 206 SCOTSDALE, AZ 85260 US Other 510(k) Applications for this Company
Contact	JEFFRY B SKIBA 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	08/30/1996
Decision Date	11/13/1996
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