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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 K173767
Device Name A. L. P. S. Clavicle Plating System
Applicant
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact Dhaval Saraiya
Correspondent
Biomet, Inc.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact Dhaval Saraiya
Regulation Number888.3030
Classification Product Code
HRS  
Date Received12/11/2017
Decision Date 04/06/2018
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
Recalls CDRH Recalls
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