BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SMR Reverse Liner

    K Number: K220792 · Decision May 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    34
    Applicant Total
    12
    Review Days
    62

    Basic Information

    Device Name
    SMR Reverse Liner
    K Number
    K220792
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3670
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    LimaCorporate S.p.A.
    Date Received
    March 18, 2022
    Decision Date
    May 19, 2022
    Product Code
    MBF
    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
    MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

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    Other Clearances by LimaCorporate S.p.A.

    K Number Device Name
    K243826 SMR Reverse HP Shoulder System
    K231099 SMR Hybrid Glenoid System
    K231925 MINIMA S System
    K223876 SMR Shoulder System
    K222807 TEMA Elbow system - Line extension
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    K212800 PRIMA Humeral System and SMR Glenosphere Ø42
    K210717 Bone Screws dia. 5,0 mm
    K201905 SMR 140° Reverse Humeral Body
    K201084 Physica system
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