BEUDAMED
    Product Code: NUD FDA class 2 21 CFR 888.3027

    Vertebroplasty Compound, Calcium Based

    Orthopedic

    The Calcium-Based Vertebroplasty Compound is a resorbable bone void filler indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. The device resorbs over time and is replaced with new bone during the healing process. It is an FDA Class 2 implant regulated under 21 CFR 888.3027 in the Orthopedic specialty, with product code NUD, requiring 510(k) clearance. The implant flag is set reflecting its surgical placement within the vertebral body. It does not carry life-sustaining support designation.

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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
    NUD
    Device Class
    FDA class 2
    Regulation Number
    888.3027
    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

    THIS DEVICE IS INDICATED FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. THE DEVICE RESORBS (TIME FRAME MAY BE INDICATED) AND IS REPLACED WITH BONE DURING THE HEALING PROCESS.