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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 K051590
Device Name T2 ANKLE ARTHRODESIS NAIL
Applicant
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact VIVIAN KELLY
Correspondent
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact VIVIAN KELLY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/15/2005
Decision Date 07/29/2005
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
Recalls CDRH Recalls
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