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510(k) Data Aggregation

    K Number
    K111908
    Device Name
    BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Date Cleared
    2011-11-29

    (147 days)

    Product Code
    HWC, 87H, HRS
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MICROFIXATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomet Microfixation Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy and sternal reconstructive surgical procedures, to promote fusion. The Biomet Microfixation Sternal Closure System is intended for use in patients with normal and poor bone quality.
    Device Description
    Biomet Microfixation Sternal Closure System contains a variety of plates and 2.4mm and 2.7mm diameter self-drilling screws with maximum length of 20mm. The tip of the screw is designed so that a predrilled hole is not required, but may be used. Material: Titanium. Sterility Information: The Biomet Microfixation Sternal Closure System will be marketed as non-sterile, single use devices. Validated steam sterilization recommendations are included in the package insert.
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    K Number
    K110574
    Device Name
    BIOMET MICROFIXATION STERNALOCK BLU STERNAL CLOSURE SYSTEM
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Date Cleared
    2011-05-18

    (78 days)

    Product Code
    HRS, 87H
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MICROFIXATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biomet Microfixation SternaLock Blu Sternal Closure System is intended for use in the stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures
    Device Description
    Biomet Microfixation Sternal Closure System contains plates and 2.4mm and 2.7mm diameter self-drilling screw with maximum length of 20mm. The screw is designed so that a predrilled hole is not required, but may be used.
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    K Number
    K091058
    Device Name
    ADKINS STRUT
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Date Cleared
    2009-07-22

    (100 days)

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

    BIOMET MICROFIXATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in surgical procedures to repair Pectus Excavatum and other chest wall deformities.
    Device Description
    The Biomet Microfixation Adkins Strut is a surgical implant intended to aid treatment of Pectus Excavatum and other sternal deformities. The strut provides the surgeon with a means to reposition bony structures (sternum, breastbone) by providing internal stabilization and fixation of the chest wall following surgical procedures such as the Ravitch procedure. The struts are available in various lengths with two holes on each end for sutures to secure the bar to the lateral chest wall. The titanium struts are used when the patient has a nickel allergy.
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    K Number
    K081067
    Device Name
    FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE)
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Date Cleared
    2008-05-09

    (24 days)

    Product Code
    JEY
    Regulation Number
    872.4760
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOMET MICROFIXATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.
    Device Description
    The Mandibular Fracture / Reconstructive Devices (TraumaOne) are comprised of a variety of titanium fracture and reconstruction plates and screws with shapes and sizes designed for internal fixation of mandibular fractures and reconstruction procedures. The screws have locking head features. The plates have threaded through holes (which allows them to work with either the locking screws) and will include straight, angle, double angle, and crescent options with various lengths and thickness.
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    K Number
    K071577
    Device Name
    BIOMET MICROFIXATION LACTOSORB PECTUS STABILIZER
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Date Cleared
    2007-09-06

    (90 days)

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

    BIOMET MICROFIXATION, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Biomet Microfixation LactoSorb® Pectus Stabilizer is intended to be used with Lorenz Pectus Support Bars cleared via K972420 and K061384 for repairing Pectus Excavatum and other sternal deformities when additional stabilization is necessary.
    Device Description
    The LactoSorb® Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Biomet Microfixation Pectus Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. The LactoSorb® Pectus Stabilizer is a resorbable implant and does not require removal.
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