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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 K003018
Device Name TITAN TIBIAL NAIL
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Applicant Contact karen ariemma
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Correspondent Contact karen ariemma
Regulation Number888.3020
Classification Product Code
HSB  
Date Received09/27/2000
Decision Date 12/15/2000
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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