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

    PERIMETER C (Titanium) Spinal System

    K Number: K153438 · Decision Mar 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    171
    Review Days
    96

    Basic Information

    Device Name
    PERIMETER C (Titanium) Spinal System
    K Number
    K153438
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Sofamor Danek USA, Inc.
    Date Received
    November 27, 2015
    Decision Date
    March 2, 2016
    Product Code
    ODP
    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
    ODP Intervertebral Fusion Device With Bone Graft, Cervical

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