BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇭 Switzerland

    DePuy Synthes MatrixSTERNUM Fixation System

    K Number: K233967 · Decision May 9, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    519
    Registration Numbers
    519
    Same Product Code
    1313
    Applicant Total
    7
    Review Days
    146

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    Basic Information

    Device Name
    DePuy Synthes MatrixSTERNUM Fixation System
    K Number
    K233967
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes GmbH
    Date Received
    December 15, 2023
    Decision Date
    May 9, 2024
    Product Code
    HRS
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HRS Plate, Fixation, Bone

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    Other Clearances by Synthes GmbH

    K Number Device Name
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    K254054 VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System
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    K241927 Synthes Graphic Case & Tray System
    K233994 VOLT™ Proximal Humerus 3.5 Plating System