BEUDAMED
    Product Code: OBM FDA class 2 21 CFR 888.3027

    Cement, Bone, Vertebroplasty, Pre-Formed, Modular

    Orthopedic

    The Pre-Formed Modular Vertebroplasty Bone Cement (product code OBM) is an orthopedic implant device used alongside PMMA bone cement cleared for vertebroplasty to reduce vertebral body fractures and restore vertebral body height in patients with compression fractures. Like product code OBL, it provides a pre-formed modular component to support the vertebroplasty procedure. This device is FDA Class 2 under regulation 888.3027 in the Orthopedic specialty, requiring 510(k) clearance, and carries an implant flag indicating it is surgically implanted.

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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
    OBM
    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

    Reduction of vertebral body fractures in conjunction with PMMA bone cement cleared for vertebroplasty and restoration of vertebral body height.