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510(k) Data Aggregation

    K Number
    K072029
    Device Name
    PHENIX VERTEBRAL BODY REPLACEMENT
    Manufacturer
    NEW BUSINESS DEVELOPMENT, LLC
    Date Cleared
    2007-10-15

    (83 days)

    Product Code
    MQP
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW BUSINESS DEVELOPMENT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Phenix™ VBR is a vertebral body replacement device intended for use in the thoracic spine (i.e., T1-L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy) due to tumor or trauma (i.e., fracture). The Phenix™ VBR is designed to restore the mechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The Phenix™ VBR is intended for use with supplemental spinal fixation systems that have been labeled for use in the thoracic spine. The interior of the Phenix™ VBR may be packed with bone graft.
    Device Description
    The Phenix™ VBR is a rectangular implant with an open center comprised of titanium, (Ti-6Al-4V). The Phenix™ VBR's superior and inferior ends have ridges to interface with the vertebral endplates to resist rotation and migration. The implant is available in a range of sizes, as well as flat and lordotic angled implants to accommodate variations in patient's anatomy. The Titanium allows for radiographic visualization.
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    K Number
    K050377
    Device Name
    NBD HEAD SCREW
    Manufacturer
    NEW BUSINESS DEVELOPMENT, LLC
    Date Cleared
    2005-04-07

    (51 days)

    Product Code
    HAW
    Regulation Number
    882.4560
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW BUSINESS DEVELOPMENT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NBD Head Screws are an accessory that is intended to support the head frame in stereotactic procedures. The head frames are supported by either a three point-of-contact or four point-of-contact position depending on the frame design.
    Device Description
    The NBD Head Screw is a single-use threaded clear anodized aluminum screw which is manufactured in lengths ranging from 33mm-57mm.
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    K Number
    K032196
    Device Name
    NBD DISPOSABLE RF CANNULAE
    Manufacturer
    NEW BUSINESS DEVELOPMENT, LLC
    Date Cleared
    2003-10-09

    (83 days)

    Product Code
    GXI, GXD
    Regulation Number
    882.4725
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW BUSINESS DEVELOPMENT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NBD Disposable RF Needle are indicated for use in radio frequency heat lesion procedures for relief of pain.
    Device Description
    Not Found
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    K Number
    K021788
    Device Name
    NBD CEMENT RESTRICTOR DEVICE
    Manufacturer
    NEW BUSINESS DEVELOPMENT, LLC
    Date Cleared
    2002-10-04

    (126 days)

    Product Code
    JDK
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    NEW BUSINESS DEVELOPMENT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NBD Cement Restrictor Device is intended for use as a cement restrictor in orthopedic surgeries such as those involving the femoral canal and tibial plateau in hip stem and total knee replacement. The NBD Cement Restrictor is NOT intended for any spinal indications.
    Device Description
    The NBD Cement Restrictor Device is a hollow, titanium, rounded rectangular frame with fenestrated surfaces on all sides and 1mm toothed spikes on opposite sides. The device is intended to be used in conjunction with standard PMMA cement.
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