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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 K021786
Device Name TITANIUM ANKLE ARTHRODESIS NAIL
Applicant
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Applicant Contact LONNIE WITHAM
Correspondent
BIOMET, INC.
56 EAST BELL DR.
WARSAW,  IN  46581 -0587
Correspondent Contact LONNIE WITHAM
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/30/2002
Decision Date 08/26/2002
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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