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510(k) Data Aggregation

    K Number
    K192873
    Device Name
    SX-One MicroKnife
    Manufacturer
    Sonex Health, Inc.
    Date Cleared
    2019-12-20

    (73 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    LXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SX-One MicroKnife is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.
    Device Description
    The Sonex Health SX-One MicroKnife is a mechanical device that uses a blade to manually transect the transverse carpal ligament. The device is provided sterile and intended for single use. The SX-One MicroKnife® consists of a thin stainless-steel shaft connected to a handpiece that is designed to be ambidextrous. A lever on the handle is activated to unlock the blade actuator and inflate the two balloons located on the lateral sides of the tip of the device. The blade actuator is used to activate a cutting blade that transects the TCL. The cutting blade is manually moved proximally and distally along a track. The purpose of the blade is to transect the transverse carpal ligament to treat carpal tunnel syndrome.
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    K Number
    K140414
    Device Name
    IMBIBE NEEDLE
    Manufacturer
    ORTHOVITA, INC.
    Date Cleared
    2014-04-01

    (42 days)

    Product Code
    LXH, IMB, KNW
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    LXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Imbibe Needle is for use in aspirating bone marrow or autologous blood by use of a syringe. The bone marrow or autologous blood may be combined with bone graft or bone void filler. The Imbibe Needle is also for use in the placement of guidewires (e.g. k-wires) during orthopedic surgery.
    Device Description
    The Imbibe Needle is a manually operated surgical instrument to assist with the aspiration of autologous blood or bone marrow and/or placing guidewires (e.g. kwires) for orthopedic surgery. These guidewires may be used to place other hardware utilized in orthopedic procedures including pedicle screws.
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    K Number
    K101609
    Device Name
    SELF RETAINING SOFT TISSUE RETRACTOR
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2010-12-09

    (184 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    LXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device is intended for use in surgical procedures to provide surgical access to the spine by placing the retractor in incision prepared by the surgeon down towards the land the sure is michael for use in surgical procedures to provide surgical access to the specifical access to the splacing .
    Device Description
    Self-Retaining Lumbar Retractor
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    K Number
    K001507
    Device Name
    MICROPERFORATION INSTRUMENT
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2000-06-14

    (30 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    LXH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K952495
    Device Name
    ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM
    Manufacturer
    ORTHOPEDIC SYSTEMS, INC.
    Date Cleared
    1996-01-22

    (237 days)

    Product Code
    LXH
    Regulation Number
    888.4540
    Why did this record match?
    Product Code :

    LXH

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