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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(k) Number K140509
Device Name BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
Applicant
Biomet Manufacturing, LLC
56 E Bell Dr.
Warsaw,  IN  46581
Applicant Contact TRACY BICKEL JOHNSON, RAC
Correspondent
Biomet Manufacturing, LLC
56 E Bell Dr.
Warsaw,  IN  46581
Correspondent Contact TRACY BICKEL JOHNSON, RAC
Regulation Number888.3510
Classification Product Code
KRO  
Date Received02/28/2014
Decision Date 05/28/2014
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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