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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 K032579
Device Name S2 NAIL SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Applicant Contact vivian kelly
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
allendale,  NJ  07401 -1677
Correspondent Contact vivian kelly
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/21/2003
Decision Date 08/29/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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