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510(k) Data Aggregation

    K Number
    K231448
    Device Name
    TANDEM Hip System
    Manufacturer
    Smith & Nephew, Inc.
    Date Cleared
    2023-07-19

    (62 days)

    Product Code
    LZY, KWY
    Regulation Number
    888.3360
    Why did this record match?
    Product Code :

    LZY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Smith & Nephew TANDEM Unipolar and Bipolar Hip System is intended for partial hip arthroplasty in skeletally mature patients. It is indicated for use in patients not suitable for total hip arthroplasty, with a non-functional femoral head due to femoral neck fracture. The TANDEM Unipolar and Bipolar head components are intended to articulate against the natural acetabulum, which requires no use of bone cement.
    Device Description
    The TANDEM Hip System is designed to be used for hemiarthroplasty as implantation of these devices replace diseased, affected, or broken femoral head and/or neck with a prosthetic component, while keeping the natural acetabulum, or hip socket, intact. The TANDEM Hip System includes the TANDEM Unipolar Hip System and TANDEM International Bipolar Hip Systems are used for partial hip replacement procedure, in which the unipolar shell are designed to articulate against the host acetabular articular cartilage and replace the femoral head and/or neck during the implantation procedure. The key difference between a unipolar and a bipolar version of the TANDEM Hip System is number of rotational points that are provided – single (unipolar) or two (bipolar) — within the socket.
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    K Number
    K111145
    Device Name
    ENDO HEAD
    Manufacturer
    MEDACTA INTERNATIONAL
    Date Cleared
    2011-08-16

    (116 days)

    Product Code
    LZY
    Regulation Number
    888.3360
    Why did this record match?
    Product Code :

    LZY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medacta® Endo Head is intended for use in combination with Medacta® Hip Prosthesis System for primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: · Femoral neck and trochanteric fractures of the proximal femur; · Osteonecrosis of the femoral head; · Revision procedures where other devices or treatments for these indications have failed.
    Device Description
    The Medacta Endo Head is a unipolar prosthesis that consists of a monobloc prosthetic femoral head made of Cobalt Chromium Molybdenum (CoCrMo ISO 5832-12) designed to articulate directly in the patient's acetabulum. It is designed to be assembled with all the Medacta stems. Three sizes (S, M and L) are available for a 12/14 Morse taper with an outer diameter varying from 40 to 56 mm with 1 mm increments between sizes.
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    K Number
    K974442
    Device Name
    PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1998-01-05

    (41 days)

    Product Code
    LZY
    Regulation Number
    888.3360
    Why did this record match?
    Product Code :

    LZY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.
    Device Description
    Pre-powdered Nitrile Examination Gloves
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