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

    ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM

    K Number: K121567 · Decision Sep 26, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    10
    Review Days
    120

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    Basic Information

    Device Name
    ORACLE LUMBAR INTERVERTEBRAL BODY FUSION CAGE SYSTEM
    K Number
    K121567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accel Spine
    Date Received
    May 29, 2012
    Decision Date
    September 26, 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 Accel Spine

    K Number Device Name
    K140219 PICASSO II MIS SPINAL SYSTEM
    K131981 CEZANNE II INTERBODY FUSION SYSTEM
    K132366 SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS
    K132365 SPONDYLOLISTHESIS SPINAL FIXATION, SPINAL PEDICLE FIXATION
    K121568 DALI SPINAL FIXATION SYSTEM
    K121078 VAN GOGH ANTERIOR CERVICAL PLATE SYSTEM
    K121136 RENOIR POSTERIOR CERVIAL FIXATION SYSTEM
    K120714 PICASSO MIS SPINAL FIXATION SYSTEM
    K121569 MATISSE ANTERIOR CERVICAL INTERBODY FUSION CAGE SYSTEM