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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
510(k) Number K963432
Device Name GUIDE WIRES FOR CANNULATED SCREWS
Applicant
ORTHOPAEDIC BIOSYSTEMS, LTD.
7320 EAST BUTHERUS
SUITE 206
SCOTSDALE,  AZ  85260
Applicant Contact JEFFRY B SKIBA
Correspondent
ORTHOPAEDIC BIOSYSTEMS, LTD.
7320 EAST BUTHERUS
SUITE 206
SCOTSDALE,  AZ  85260
Correspondent Contact JEFFRY B SKIBA
Regulation Number888.3030
Classification Product Code
LXT  
Date Received08/30/1996
Decision Date 11/13/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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