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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 K012798
Device Name INTEX SCREW
Applicant
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact DALENE T BINKLEY
Correspondent
Biomet, Inc.
P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact DALENE T BINKLEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/21/2001
Decision Date 11/16/2001
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
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