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

    Smart SPACE Shoulder Planner and 3D Positioners

    K Number: K222405 · Decision Dec 20, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    25
    Applicant Total
    64
    Review Days
    133

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    Basic Information

    Device Name
    Smart SPACE Shoulder Planner and 3D Positioners
    K Number
    K222405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3660
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lima Corporate S.P.A.
    Date Received
    August 9, 2022
    Decision Date
    December 20, 2022
    Product Code
    QHE
    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
    QHE Shoulder Arthroplasty Implantation System

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    Other Clearances by Lima Corporate S.P.A.

    K Number Device Name
    K252352 SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System
    K251718 ArTT Augments and Buttresses and Bone Screws
    K243826 SMR Reverse HP Shoulder System
    K250980 Physica System (Physica CR Porous Femoral components)
    K243615 Physica Porous Femoral Components
    K234011 AMF TT Cones
    K233712 PRIMA Humeral System; PRIMA TT Glenoid
    K231099 SMR Hybrid Glenoid System
    K231925 MINIMA S System
    K221758 SMR Stemless Anatomic
    Search all 64 clearances from Lima Corporate S.P.A. →