BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Stryker Resorbable Fixation System

    K Number: K213777 · Decision Feb 4, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    2
    Review Days
    63

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    Basic Information

    Device Name
    Stryker Resorbable Fixation System
    K Number
    K213777
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Leibinger Micro Implants
    Date Received
    December 3, 2021
    Decision Date
    February 4, 2022
    Product Code
    JEY
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JEY Plate, Bone

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    Other Clearances by Stryker Leibinger Micro Implants

    K Number Device Name
    K051603 STRYKER INJECTABLE CEMENT