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

    Agilon Strip

    K Number: K193487 · Decision Mar 30, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    8
    Review Days
    104

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    Basic Information

    Device Name
    Agilon Strip
    K Number
    K193487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biogennix, LLC
    Date Received
    December 17, 2019
    Decision Date
    March 30, 2020
    Product Code
    MQV
    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
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Biogennix, LLC

    K Number Device Name
    K240621 Morpheus® Moldable; Agilon® Moldable
    K193168 Agilon Moldable
    K190371 Morpheus-C
    K181337 Sypher Spacer System
    K141798 SYPHER SPACER SYSTEM
    K132377 OSTEOSPAN MORPHEUS
    K093342 BIOGENNIX RPC