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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K033286
Device Name ODI TALON LONG PROXIMAL FEMORAL NAIL SYSTEM
Applicant
Orthopedic Designs, Inc. (Odi)
9521 International Court N.
St. Petersburg,  FL  33716
Applicant Contact JOHN SODEIKA
Correspondent
Orthopedic Designs, Inc. (Odi)
9521 International Court N.
St. Petersburg,  FL  33716
Correspondent Contact JOHN SODEIKA
Regulation Number888.3020
Classification Product Code
HSB  
Date Received10/14/2003
Decision Date 01/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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