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510(k) Data Aggregation

    K Number
    K242799
    Device Name
    PliaFX Flo
    Manufacturer
    LifeNet Health
    Date Cleared
    2024-11-21

    (65 days)

    Product Code
    MBP, MOV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    LifeNet Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.
    Device Description
    PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.
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    K Number
    K201338
    Device Name
    Allograft MIS Delivery System
    Manufacturer
    LifeNet Health
    Date Cleared
    2020-07-13

    (54 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    LifeNet Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.
    Device Description
    The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly. The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.
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    K Number
    K081438
    Device Name
    MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT
    Manufacturer
    LifeNet Health
    Date Cleared
    2008-10-17

    (148 days)

    Product Code
    DXZ
    Regulation Number
    870.3470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LifeNet Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MatrACELL™ Decellularized Pulmonary Artery Patch Allograft is indicated for repair of the right ventricular outflow tract.
    Device Description
    derived from human pulmonary artery tissue and subsequently decellularized. The product is provided in multiple sizes for clinical use.
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    K Number
    K053098
    Device Name
    OPTIUM DBM GEL AND PUTTY
    Manufacturer
    LIFENET
    Date Cleared
    2005-11-28

    (25 days)

    Product Code
    MBP, MQV
    Regulation Number
    888.3045
    Why did this record match?
    Applicant Name (Manufacturer) :

    LIFENET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are indicated to be placed into the bony voids or gaps of the skeletal system (e.g., extremities, spine, and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products provide a bone void filler that remodels into the recipient's skeletal system.
    Device Description
    These devices are comprised of sterile USP grade glycerol/glycerin and combined with human demineralized cortical bone at the point of manufacture.
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