BEUDAMED
    Product Code: NJA FDA class 2 21 CFR 888.3040

    Accessory, System, External Fixator, Containing Antimicrobial Agent

    Orthopedic

    The Antimicrobial-Containing External Fixator Accessory is an implantable sleeve used around orthopedic pins and wires during external bone fixation, impregnated with gentamicin antibiotic that is released over time to inhibit bacterial colonization at the pin or wire interface. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJA and regulation 21 CFR 888.3040 in the Orthopedic specialty. The device is flagged as an implant but is not life-sustaining.

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    510(k)s
    0
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    NJA
    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
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    Summary Malfunction Reporting

    Definition

    The device is intended to be used as an accessory surrounding orthopedic pins and wires during external fixation of bones. The sleeve is impregnated with antibiotic (gentamicin) which is released over time in order to inhibit bacterial colonization on the pin/wire.