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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K014189
Device Name ODI TALON INTRAMEDULLARY HIP NAIL
Applicant
Orthopedic Designs, Inc.
6965 1st. Ave. N.
St. Petersburg,  FL  33710 -8303
Applicant Contact JOHN SODEIKA
Correspondent
Orthopedic Designs, Inc.
6965 1st. Ave. N.
St. Petersburg,  FL  33710 -8303
Correspondent Contact JOHN SODEIKA
Regulation Number888.3030
Classification Product Code
JDS  
Date Received12/21/2001
Decision Date 03/21/2002
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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