BEUDAMED
    Product Code: NEH FDA class 2 21 CFR 878.4300

    Anchor, Fascial

    General, Plastic Surgery

    The Anchor, Fascial (product code NEH) is a surgical implant used to secure fascia or soft tissue to bone, commonly employed in hernia repair, pelvic floor reconstruction, or tendon reattachment procedures. It is an FDA Class 2 device within the General and Plastic Surgery specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device carries an implant designation and is not flagged as life-sustaining or GMP-exempt.

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

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    Basic Information

    Product Code
    NEH
    Device Class
    FDA class 2
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    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
    K010277 AMS FASCIAL-ANCHORING SYSTEM