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510(k) Data Aggregation

    K Number
    K231819
    Device Name
    Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
    Manufacturer
    Innovate Orthopaedics Limited
    Date Cleared
    2023-09-05

    (76 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovate Orthopaedics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quick-Start Orthopaedic Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
    Device Description
    The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.
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    K Number
    K212547
    Device Name
    Quick-Start Screws
    Manufacturer
    Innovate Orthopaedics Limited
    Date Cleared
    2021-12-30

    (139 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Innovate Orthopaedics Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quick-Start Screws are indicated for interference fixation of soft tissue grafts and/or bone-tendon-bone grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.
    Device Description
    The Innovate Orthopaedics Quick-Start Screw family of products are interference screws indicated for the fixation of soft tissue or bone-tendon-bone grafts in ligament reconstruction procedures. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.
    Ask a Question

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