BEUDAMED
    Product Code: NDJ FDA class 2 21 CFR 888.3040

    Screw, Fixation, Bone, Non-Spinal, Metallic

    Orthopedic

    The Screw, Fixation, Bone, Non-Spinal, Metallic (product code NDJ) is a metallic orthopedic screw used to achieve rigid fixation of bone fractures and osteotomies in non-spinal applications. It is 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 surgically placed metallic implant, it carries an implant flag and is not flagged as life-sustaining or GMP-exempt.

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

    Basic Information

    Product Code
    NDJ
    Device Class
    FDA class 2
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    1

    Device Characteristics

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

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.