BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BIOMET LATERAL SPACER SYSTEM

    K Number: K122989 · Decision Oct 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    13
    Review Days
    28

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    Basic Information

    Device Name
    BIOMET LATERAL SPACER SYSTEM
    K Number
    K122989
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biomet Spine (Aka Ebi, LLC)
    Date Received
    September 26, 2012
    Decision Date
    October 24, 2012
    Product Code
    MAX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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    Other Clearances by Biomet Spine (Aka Ebi, LLC)

    K Number Device Name
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    K131615 POLARIS SPINAL SYSTEM
    K123549 POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM
    K123451 POLARIS SPINAL SYSTEM - BALLISTA II RODS
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