BEUDAMED
    Product Code: LZE FDA class 1 21 CFR 888.1520

    Isometer

    Orthopedic

    The Isometer (product code LZE) is an orthopedic diagnostic instrument used to measure the isometric point of ligament origins during knee or other joint surgeries, assisting surgeons in determining the optimal placement for ligament reconstruction graft tunnels. Regulated under 21 CFR 888.1520 and classified as a Class 1 device subject only to general controls, it falls under the Orthopedic specialty. It is not an implant, is not life-sustaining, and is not 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
    LZE
    Device Class
    FDA class 1
    Regulation Number
    888.1520
    Medical Specialty
    Orthopedic
    Review Panel
    OR
    Submission Type
    4

    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
    K950178 PHARMA-PLAST PURELINE(TM) COMFORT(TM) & CLINI SOFS PLUS SUBCUTANEOUS INFUSION SET