BEUDAMED
    Product Code: HSR FDA class 1 21 CFR 888.5890

    Unit, Traction, Hip, Non-Powered, Non-Penetrating

    Orthopedic

    A non-powered, non-penetrating hip traction unit is an orthopedic device used to apply controlled traction forces to the hip joint without the use of an external power source or skin-penetrating hardware, typically used to manage hip fractures or dislocations and reduce pain. It is classified as an FDA Class 1 device under 21 CFR 888.5890, indicating low risk and general controls only. Product code HSR falls under the Orthopedic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) regulations.

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    510(k)s
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HSR
    Device Class
    FDA class 1
    Regulation Number
    888.5890
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    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
    K780763 ENTRAX TRACTION UNIT

    FEI Numbers

    This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.