BEUDAMED
    Product Code: ISM FDA class 1 21 CFR 890.3025

    Pylon, Post Surgical

    Physical Medicine

    A post-surgical pylon is a temporary prosthetic structural tube used in the early postoperative period to provide basic weight-bearing function for lower limb amputees prior to fitting with a definitive prosthesis. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is ISM, regulated under 21 CFR 890.3025, within the Physical Medicine medical specialty. This device is GMP exempt.

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    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    ISM
    Device Class
    FDA class 1
    Regulation Number
    890.3025
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    4

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.