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510(k) Data Aggregation

    K Number
    K991405
    Device Name
    OMNI-FIX, HUMERAL NAIL
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1999-06-29

    (68 days)

    Product Code
    KTW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cases of fracture of the long arm bones are not uncommon and are usually caused by Cases of the surgical re-construction of the humeral is necessary to restore the patients natural alignment of the arm. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections together, until natural healing of the fracture occurs. The separate fractured bone societic when the fracture is healed for full load bearing.
    Device Description
    The Omni-Fix, intra-medallary nails were designed to be used for fracture stabilization and fixation of the femur and tibia. Nails are manufactured from Titanium Alloy (Ti-6A1-4V) wrought bar stock material as per ISO 5832 part 3 and ASTM F136-84.
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    K Number
    K990523
    Device Name
    B2C, ESPACE REVISION CUP SYSTEM
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1999-04-30

    (70 days)

    Product Code
    LPH
    Regulation Number
    888.3358
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Groupe Lepine B2C Espace, revision acetabular cup system is intended to be used as the pelvic component of a total hip arthoplasty. The acetabular component geometry has been designed to fill large acetabular defects in the floor and superior aspects of the acetabular cavity. It can be implanted either as a press fit cup with bone screw fixation or cemented into the cavity.
    Device Description
    Not Found
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    K Number
    K990307
    Device Name
    OMNI-FIX, NAIL SYSTEM
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1999-04-01

    (59 days)

    Product Code
    KTW
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cases of fracture of the long leg bones are not uncommon and are usually caused by trauma. The surgical re-construction of either the tibia or femur is necessary to restore the patient back their natural alignment and gait. The intra-medullary nail is used as a scaffold to hold the separate fractured bone sections in alignment until natural healing occurs. The nails creates a sound foundation for the partial, then when healed full load bearing.
    Device Description
    Not Found
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    K Number
    K972411
    Device Name
    LINK CEMENT PLUG
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1997-08-29

    (64 days)

    Product Code
    LZN
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Link femoral cement restrictor plug system is used to constrict the flow of bone cement (PMMA) into the distal section of the femoral canal during a cemented total hip arthoplasty.
    Device Description
    Not Found
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    K Number
    K970284
    Device Name
    ARTOS, DIPLOS SYSTEM
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1997-04-21

    (87 days)

    Product Code
    KWY
    Regulation Number
    888.3390
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970084
    Device Name
    LINK CERCLAGE WIRE SYSTEM
    Manufacturer
    TURNKEY INTERGRATION USA, INC.
    Date Cleared
    1997-03-13

    (63 days)

    Product Code
    JDQ
    Regulation Number
    888.3010
    Why did this record match?
    Applicant Name (Manufacturer) :

    TURNKEY INTERGRATION USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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