BEUDAMED
    Product Code: HAB FDA class 1 21 CFR 878.4820

    Saw, Powered, And Accessories

    General, Plastic Surgery

    The Powered Saw and Accessories is a surgical power tool used to cut bone during a wide range of surgical procedures, including orthopedic, plastic, and general surgery, with accessories tailored to specific cutting requirements. It is classified as a Class 1 device (lowest risk), subject to general controls only. The product code is HAB under regulation 21 CFR 878.4820 in the General, Plastic Surgery specialty. No implant, life-sustaining, GMP exempt, or third-party review flags apply.

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    510(k)s
    2
    FEI Numbers
    59
    Registration Numbers
    59
    Unique Applicants
    2
    Years Active
    8

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    Basic Information

    Product Code
    HAB
    Device Class
    FDA class 1
    Regulation Number
    878.4820
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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 2 510(k) clearances via K numbers.

    K Number Device Name
    K012320 POWERPRO BATTERY SYSTEM
    K935517 SNAP STERNUM SAW

    FEI Numbers

    This FDA classification entry is associated with 59 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 59 registration numbers. Click on an entry to view related FDA registrations.