BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    SignaSure Dual Mobility System

    K Number: K211742 · Decision Jan 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    189
    Registration Numbers
    189
    Same Product Code
    158
    Applicant Total
    44
    Review Days
    214

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    Basic Information

    Device Name
    SignaSure Dual Mobility System
    K Number
    K211742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3353
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Signature Orthopaedics Pty, Ltd.
    Date Received
    June 7, 2021
    Decision Date
    January 7, 2022
    Product Code
    MEH
    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
    MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

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