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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 K063570
Device Name BIOMET TIBIAL LOCKING NAIL SYSTEM
Applicant
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
PO BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact BECKY EARL
Correspondent
BIOMET MANUFACTURING CORP.
56 EAST BELL DRIVE
PO BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact BECKY EARL
Regulation Number888.3020
Classification Product Code
HSB  
Date Received11/29/2006
Decision Date 02/27/2007
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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