BEUDAMED
    Product Code: QLR FDA class 2 21 CFR 888.4520

    Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices

    Orthopedic

    Manual Instruments Designed For Use With Non-Fusion Spinous Process Spacer Devices are Class 2 orthopedic surgical instruments intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices used in non-fusion spinal procedures. They require 510(k) clearance and are regulated under 21 CFR 888.4520 within the Orthopedic medical specialty. The product code is QLR. The devices are not implants and are not flagged as 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
    QLR
    Device Class
    FDA class 2
    Regulation Number
    888.4520
    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 devices are intended to manipulate tissue or implant materials for the positioning, alignment, placement, or removal of spinous process spacer devices for non-fusion use.