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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 K131670
Device Name LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT)
Applicant
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Applicant Contact SUZANA OTANO
Correspondent
Biomet, Inc.
56 E. Bell Dr. P.O. Box 587
Warsaw,  IN  46581 -0587
Correspondent Contact SUZANA OTANO
Regulation Number888.3030
Classification Product Code
HRS  
Date Received06/07/2013
Decision Date 07/03/2013
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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