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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name plate, fixation, bone
510(k) Number K210192
Device Name A.L.P.S. Clavicle Plating System
Biomet Inc.
56 East Bell Drive
warsaw,  IN  46581
Applicant Contact kyle ponce
Biomet Inc.
56 East Bell Drive
warsaw,  IN  46581
Correspondent Contact kyle ponce
Regulation Number888.3030
Classification Product Code
Date Received01/25/2021
Decision Date 02/19/2021
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No