BEUDAMED
    Product Code: KWO FDA class 2 21 CFR 888.3760

    Prosthesis, Wrist, Carpal Scaphoid

    Orthopedic

    The Carpal Scaphoid Wrist Prosthesis is an orthopedic implant used to replace the scaphoid bone of the wrist, typically employed following scaphoid non-union, avascular necrosis, or severe scaphoid fracture to maintain carpal height and wrist mechanics. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWO, regulated under 21 CFR 888.3760, in the Orthopedic medical specialty. This device is an implant.

    View on FDA
    510(k)s
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    KWO
    Device Class
    FDA class 2
    Regulation Number
    888.3760
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K864490 SWANSON TITANIUM CARPAL SCAPHOID IMPLANT

    FEI Numbers

    This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.