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

    Atlas Percussion Adjusting Instrument

    K Number: K172536 · Decision Jun 20, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    31
    Applicant Total
    7
    Review Days
    302

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    Basic Information

    Device Name
    Atlas Percussion Adjusting Instrument
    K Number
    K172536
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Spinalight, Inc.
    Date Received
    August 22, 2017
    Decision Date
    June 20, 2018
    Product Code
    LXM
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LXM Manipulator, Plunger-Like Joint

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    Other Clearances by Spinalight, Inc.

    K Number Device Name
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    K955540 HAND HELD ATLAS INSTRUMENT
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    K945954 MODELS 4100 AND 4300 MULTITHERAPY
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