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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 K122770
Device Name BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831
Applicant
Biomet Manufacturing Corp
56 Bell Dr.
Warsaw,  IN  46580
Applicant Contact PATRICIA SANDBORN BERES
Correspondent
Biomet Manufacturing Corp
56 Bell Dr.
Warsaw,  IN  46580
Correspondent Contact PATRICIA SANDBORN BERES
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received09/10/2012
Decision Date 03/28/2013
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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