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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, Single Component
510(k) Number K991405
Device Name OMNI-FIX, HUMERAL NAIL
Applicant
Turnkey Intergration USA, Inc.
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Applicant Contact DOUGLAS W STUART
Correspondent
Turnkey Intergration USA, Inc.
962 S. Tamiami Trl. Suite 203
Sarasota,  FL  34326
Correspondent Contact DOUGLAS W STUART
Regulation Number888.3030
Classification Product Code
KTW  
Date Received04/22/1999
Decision Date 06/29/1999
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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