BEUDAMED
    Product Code: HTM FDA class 3

    Stimulator, Osteogenesis, Electric, Battery-Operated, Invasive

    Unknown

    An invasive, battery-operated electrical osteogenesis stimulator is a device surgically implanted or inserted near a bone fracture site to deliver low-level electrical current and promote bone healing in cases of delayed unions or nonunions. It is classified as an FDA Class 3 device, the highest risk category, requiring a Premarket Approval (PMA) application demonstrating safety and effectiveness. Product code HTM is reviewed under the Orthopedic panel; no regulation number or medical specialty code is assigned in the current classification database.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    HTM
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

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