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510(k) Data Aggregation

    K Number
    K120590
    Device Name
    DILATOR TUBE SET
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2013-05-07

    (434 days)

    Product Code
    PDQ, GXZ
    Regulation Number
    874.1820
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOROS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dilator Tube Set is intended for use in surgical procedures to provide surgical access by dilating the soft tissue to the intended surgical site and to identify motor nerves, spinal nerve roots and to aid the surgeon in assessing nerve function during surgery. The Dilator Tube Set is single use only.
    Device Description
    Not Found
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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?
    Applicant Name (Manufacturer) :

    KOROS USA, INC.

    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
    K082399
    Device Name
    PECTUS STRUT
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2009-11-05

    (442 days)

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

    KOROS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device is intended for use in surgical procedures to repair Pectus Excavatum and sternal deformities.
    Device Description
    Not Found
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    K Number
    K071338
    Device Name
    FLEX ARM RETRACTOR SYSTEM
    Manufacturer
    KOROS USA, INC.
    Date Cleared
    2007-05-29

    (15 days)

    Product Code
    GZT
    Regulation Number
    882.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    KOROS USA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room environment.
    Device Description
    Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield
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