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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name screw, fixation, bone
510(k) Number K140891
Device Name BIOMET CANNULATED SCREW SYSTEM
Applicant
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Applicant Contact VICTORIA SCHEITLIN
Correspondent
BIOMET, INC.
56 EAST BELL DR.
BOX 587
WARSAW,  IN  46581 -0587
Correspondent Contact VICTORIA SCHEITLIN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received04/08/2014
Decision Date 06/03/2014
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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