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510(k) Data Aggregation

    K Number
    K243945
    Device Name
    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
    Manufacturer
    SurGenTec LLC
    Date Cleared
    2025-04-24

    (125 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    SurGenTec LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) is indicated for aspiration of bone marrow or autologous blood. The ALARA BMA Neuro Access Kit is indicated for pedicle pilot hole preparation, locating, and identifying spinal roots / nerves by providing proximity feedback. The ALARA BMAC Needle is intended for use in harvesting core biopsy samples of cancellous bone and/or bone marrow.
    Device Description
    The ALARA BMA Neuro Access Kit utilizes a neuromonitoring platform in providing the surgeon with nerve / root location feedback during the approach to a pedicle to support a guidewire placement. The ALARA BMAN and ALARA BMAC Kit includes various single-use needles designed for bone marrow aspiration and aspiration of autologous blood.
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    K Number
    K243835
    Device Name
    TiLink-P SI Joint Fusion System
    Manufacturer
    SurGenTec LLC
    Date Cleared
    2024-12-27

    (14 days)

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

    SurGenTec LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TiLink-P Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
    Device Description
    The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments (sterile or non-sterile). The TiLink-P SI Joint Fusion System may be used via lateral or posterior oblique. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
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    K Number
    K242414
    Device Name
    TiLink-P Joint Fusion System
    Manufacturer
    SurGenTec LLC
    Date Cleared
    2024-11-21

    (99 days)

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

    SurGenTec LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TiLink-P Joint Fusion System is intended for sacrolliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
    Device Description
    The TiLink-P SI Joint Fusion System contains various orthopedic instruments to assist the user in implanting a titanium sacroiliac implant into the sacroiliac joint to transfix the joint. The SurGenTec TiLink-P SI Joint Fixation System includes TiLink Implants and associated Instruments. The TiLink-P SI Joint Fusion System fixates the sacroiliac joint by transfixing the cortices of the ilium and cortices of the sacrum. The TiLink-P Compression Anchor is positioned so that it spans the cortices of ilium and cortices of sacrum, the TiLink-P Locking Screw is inserted through the TiLink-P Compression Anchor and across the SI Joint via a lateral approach, compressing the joint. Bone graft material is used with the TiLink-P SI Joint Fusion System to facilitate bone growth.
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