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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 K992063
Device Name OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact MARYBETH NAUGHTON
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent Contact MARYBETH NAUGHTON
Regulation Number888.3020
Classification Product Code
HSB  
Date Received06/18/1999
Decision Date 09/03/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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