BEUDAMED
    Product Code: HWW FDA class 1 21 CFR 888.4540

    Countersink

    Orthopedic

    A countersink is an orthopedic instrument used to create a conical recess in bone so that a screw head sits flush with or below the bone surface, preventing prominence and improving implant seating. It is classified as an FDA Class 1 device under 21 CFR 888.4540, indicating low risk and general controls only. Product code HWW falls under the Orthopedic medical specialty.

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    510(k)s
    0
    FEI Numbers
    111
    Registration Numbers
    111
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    HWW
    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

    FEI Numbers

    This FDA classification entry is associated with 111 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 111 registration numbers. Click on an entry to view related FDA registrations.