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

    InterForm Cervical Interbody Cage System

    K Number: K161608 · Decision Sep 30, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    339
    Registration Numbers
    339
    Same Product Code
    348
    Applicant Total
    6
    Review Days
    112

    Basic Information

    Device Name
    InterForm Cervical Interbody Cage System
    K Number
    K161608
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Next Orthosurgical
    Date Received
    June 10, 2016
    Decision Date
    September 30, 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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    Other Clearances by Next Orthosurgical

    K Number Device Name
    K242509 HAnano InterFuse(R) Modular Interbody
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