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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 K102413
Device Name FUZE: INTRAMEDULLARY INTERNAL FIXATION NAIL
Applicant
VILEX, INC.
111 MOFFITT STREET
MCMINNVILLE,  TN  37110
Applicant Contact ABE LAVI
Correspondent
VILEX, INC.
111 MOFFITT STREET
MCMINNVILLE,  TN  37110
Correspondent Contact ABE LAVI
Regulation Number888.3020
Classification Product Code
HSB  
Date Received08/24/2010
Decision Date 11/14/2011
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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