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

    VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder

    K Number: K200587 · Decision Aug 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    172

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    Basic Information

    Device Name
    VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder
    K Number
    K200587
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Orthosensor, Inc.
    Date Received
    March 6, 2020
    Decision Date
    August 25, 2020
    Product Code
    ONN
    Advisory Committee
    Neurology
    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
    ONN Intraoperative Orthopedic Joint Assessment Aid

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    K150372 VERASENSE Knee System
    K131767 ORTHOSENSOR KNEE BALANCER, VERASENSE KNEE SYSTEM
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