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

    Polaris Spinal Growth System

    K Number: K180227 · Decision Mar 15, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    42
    Registration Numbers
    42
    Same Product Code
    13
    Applicant Total
    15
    Review Days
    48

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    Basic Information

    Device Name
    Polaris Spinal Growth System
    K Number
    K180227
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zimmer Biomet Spine, Inc.
    Date Received
    January 26, 2018
    Decision Date
    March 15, 2018
    Product Code
    PGM
    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
    PGM Growing Rod System

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