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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K012503
Device Name METAL SCREW ANCHOR
Applicant
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Applicant Contact SARA B SHULTZ
Correspondent
Biomet Manufacturing, Inc.
56 E Bell Dr.
Warsaw,  IN  46581 -0587
Correspondent Contact SARA B SHULTZ
Regulation Number888.3040
Classification Product Code
MBI  
Date Received08/03/2001
Decision Date 10/22/2001
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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