BEUDAMED
    Product Code: NDD FDA class 2 21 CFR 888.3010

    Cerclage, Fixation, Metallic

    Orthopedic

    The Cerclage, Fixation, Metallic (product code NDD) is an orthopedic implant used to encircle and bind bone fragments together, commonly employed in fracture fixation of long bones or in periprosthetic fracture management. It is classified as an FDA Class 2 device within the Orthopedic specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. As a metallic implant placed in the body, it carries an implant designation.

    View on FDA
    510(k)s
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    —

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    Basic Information

    Product Code
    NDD
    Device Class
    FDA class 2
    Regulation Number
    888.3010
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    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
    K003618 WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014