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510(k) K131393

MAK OSS FEMORAL KNEE COMPONENTS by Biomet Orthopedics Corp. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2013
Date Received
May 15, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
Review Panel
OR
Submission Type

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