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

    Life Spine Metatarsal Hemi Implant

    K Number: K161279 · Decision Feb 1, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    45
    Applicant Total
    84
    Review Days
    271

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    Basic Information

    Device Name
    Life Spine Metatarsal Hemi Implant
    K Number
    K161279
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3730
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Life Spine, Inc.
    Date Received
    May 6, 2016
    Decision Date
    February 1, 2017
    Product Code
    KWD
    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
    KWD Prosthesis, Toe, Hemi-, Phalangeal

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