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510(k) K193280

MedCAD® AccuPlate® Patient-Specific Plate by Medcad — Product Code JEY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 2021
Date Received
November 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Bone
Device Class
Class II
Regulation Number
872.4760
Review Panel
DE
Submission Type

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