BEUDAMED
    Product Code: LYP FDA class 2 21 CFR 888.3050

    Accessories, Fixation, Spinal Interlaminal

    Orthopedic

    The Spinal Interlaminal Fixation Accessories (product code LYP) are orthopedic implant components used in spinal fixation surgery to augment interlaminal stabilization systems, providing additional support across laminar structures of the spine. Regulated under 21 CFR 888.3050 and classified as a Class 2 device, they require a 510(k) premarket notification and are flagged as implants. The devices fall under the Orthopedic specialty. They are not life-sustaining.

    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
    LYP
    Device Class
    FDA class 2
    Regulation Number
    888.3050
    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
    K890185 C-S IMPACTOR