BEUDAMED
    Product Code: NOV FDA class 2 21 CFR 888.3030

    Anchor, Suture, Bone Fixation, Metallic

    Orthopedic

    The metallic bone fixation suture anchor is an orthopedic implant intended to anchor suture into bone, specifically for suspension of the nasal valve and for attachment of suture to the lower orbital rim. It is classified as FDA Class 2 under regulation 888.3030 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag. Product code NOV is not eligible for third-party review and is not a life-sustaining device.

    View on FDA
    510(k)s
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    NOV
    Device Class
    FDA class 2
    Regulation Number
    888.3030
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    Definition

    This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.

    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
    K032078 MITEK MICRO QUICKANCHOR

    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.