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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 K131393
Device Name MAK OSS FEMORAL KNEE COMPONENTS
Applicant
Biomet Orthopedics Corp.
56 E. Bell Dr.
Warsaw,  IN  46582
Applicant Contact GARY BAKER
Correspondent
Biomet Orthopedics Corp.
56 E. Bell Dr.
Warsaw,  IN  46582
Correspondent Contact GARY BAKER
Regulation Number888.3510
Classification Product Code
KRO  
Date Received05/15/2013
Decision Date 10/24/2013
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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