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510(k) Data Aggregation

    K Number
    K162237
    Device Name
    XO1 Knee Balancing System
    Manufacturer
    XPANDORTHO, INC.
    Date Cleared
    2017-04-25

    (259 days)

    Product Code
    ONN
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    XPANDORTHO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.
    Device Description
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