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510(k) K244039

MedalOne Total Knee System by Suzhou Microport Orthorecon Co., Ltd. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2025
Date Received
December 30, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

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