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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 K193092
Device Name TunneLoc Tibial Fixation Device
Applicant
Biomet Inc.
56 East Bell Drive, PO Box 587
Warsaw,  IN  46582
Applicant Contact Haley Pioch
Correspondent
Biomet Inc.
56 East Bell Drive, PO Box 587
Warsaw,  IN  46582
Correspondent Contact Haley Pioch
Regulation Number888.3040
Classification Product Code
MBI  
Subsequent Product Code
HWC  
Date Received11/06/2019
Decision Date 01/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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