BEUDAMED
    Product Code: OBL FDA class 2 21 CFR 888.3027

    Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty

    Orthopedic

    The Pre-Formed Modular Polymeric Vertebroplasty Bone Cement (product code OBL) is an orthopedic device used in conjunction with PMMA bone cement cleared for vertebroplasty to reduce vertebral body fractures and restore vertebral body height. It is designed as a pre-shaped polymeric adjunct to complement cement delivery during vertebroplasty procedures. This device is FDA Class 2 under regulation 888.3027 in the Orthopedic specialty, requiring 510(k) clearance, and is notable for carrying an implant flag indicating it is implanted in the body.

    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
    OBL
    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
    —
    Summary Malfunction Reporting

    Definition

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

    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
    K063606 MODIFICATION TO STAXX FX SYSTEM