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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 K043431
Device Name GAMMA3 NAIL SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Applicant Contact JENNIFER KOSOY
Correspondent
HOWMEDICA OSTEONICS CORP.
325 Corporate Drive
Mahwah,  NJ  07430
Correspondent Contact JENNIFER KOSOY
Regulation Number888.3020
Classification Product Code
HSB  
Date Received12/13/2004
Decision Date 02/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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