BEUDAMED
    Product Code: MBS FDA class 3

    Filler, Bone Void, Non-Osteoinduction

    Unknown

    The non-osteoinductive bone void filler is an orthopedic implant material used to fill bone defects and cavities, providing structural support and a scaffold for bone healing without actively stimulating new bone formation through osteoinduction. It is classified as FDA Class III, requiring Premarket Approval (PMA) with clinical evidence of safety and effectiveness. The product code is MBS and it carries an implant flag; no regulation number or formal medical specialty has been assigned. It does not sustain life.

    View on FDA
    510(k)s
    0
    FEI Numbers
    8
    Registration Numbers
    8
    Unique Applicants
    0
    Years Active
    —

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    Basic Information

    Product Code
    MBS
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    OR
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✓
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    FEI Numbers

    This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.