BEUDAMED
    Product Code: HWK FDA class 1 21 CFR 888.4540

    Trephine

    Orthopedic

    A trephine is a cylindrical orthopedic cutting instrument with a saw-toothed circular end used to core out a plug of bone, commonly used for bone biopsy, graft harvest, or preparation of a bone socket for implant placement. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating minimal risk subject only to general controls. Product code HWK falls under the Orthopedic medical specialty.

    View on FDA
    510(k)s
    1
    FEI Numbers
    127
    Registration Numbers
    127
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    HWK
    Device Class
    FDA class 1
    Regulation Number
    888.4540
    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
    K851339 PRECISION HARVEST & INLAY INSTRUMENT SET

    FEI Numbers

    This FDA classification entry is associated with 127 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 127 registration numbers. Click on an entry to view related FDA registrations.