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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 K091976
Device Name BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL
Applicant
BIOMET TRAUMA
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Applicant Contact MARGARET CROWE
Correspondent
BIOMET TRAUMA
100 INTERPACE PARKWAY
PARSIPPANY,  NJ  07054
Correspondent Contact MARGARET CROWE
Regulation Number888.3020
Classification Product Code
HSB  
Date Received07/01/2009
Decision Date 08/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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