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510(k) Data Aggregation

    K Number
    K061748
    Device Name
    FRAGMENT PLATE SYSTEM
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2006-07-17

    (26 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed Mini Fragment Plates are intended for essentially non load bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomax, illofacial skeleton.
    Device Description
    The proposed Mini Fragment Plates are a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Fragment Plates that are provided in the following design configurations: Straight, Y, Right Hockey Stick, and Left Hockey Stick. Pegs; Screws; and K-Wires. Included in the sterilization tray are the following re-useable instruments: Peg drivers, Other standard surgical tools. In addition, the following are non-reusable instruments included in the sterilization tray: F.A.S.T. Guide Technology™ Drill Guide, Drill bits.
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    K Number
    K060864
    Device Name
    MULTIDIRECTIONAL THREADED PEG
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2006-04-28

    (29 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
    Device Description
    The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.
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    K Number
    K060294
    Device Name
    DIAPHYSEAL PLATE
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2006-03-22

    (44 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The proposed Diaphyseal Plate is intended for the fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia, and fibula, particularly in osteopenic bone.
    Device Description
    The proposed Diaphyseal Plate is fabricated from 316L Stainless Steel and is available in five configurations - 6, 8, 10, 12, and 14 hole plate configuration. The proposed Diaphyseal Plate has both slotted holes, for accommodating the Multi-Directional Screws, and round holes for accommodating either Multi-Directional or 90° Lock Screws. 90° Set Screws are used to secure the 90° Lock Screws within the plate to prevent backout.
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    K Number
    K060290
    Device Name
    SHOULDER FIXATION SYSTEM
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2006-02-27

    (21 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
    Device Description
    The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: Shoulder Plates Shoulder Nail Plates Multidirectional and 90° Lock Screws 90° Set Screws Pegs Included in the sterilization tray are the following re-useable instruments: Peg drivers Other standard surgical tools.
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    K Number
    K052294
    Device Name
    SHOULDER NAIL PLATE
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2005-10-21

    (59 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Shoulder Nail Plate of the Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
    Device Description
    The bilaterally symmetric Shoulder Nail Plate is intended to treat fractures in both left and right Humerus. The plate segment of the Shoulder Nail Plate is intended to be attached to the metaphysis of the humerus. The nail segment of the Shoulder Nail Plate is intended to be inserted into the humeral diaphysis for optimal stabilization of the fracture.
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    K Number
    K052248
    Device Name
    DORSAL NAIL PLATE, ANATOMICAL
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2005-09-14

    (27 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dorsal Nail Plate™, Anatomical is intended for the fixation of fractures and osteotomies involving the distal Radius.
    Device Description
    The Dorsal Nail Plate™, Anatomical is intended to treat fractures in both left and right Radius. The distal segment of the nail plate is intended to be attached to the dorsal surface of the distal Radius. The proximal segment of the nail plate is intended to be inserted into the Radial shaft.
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    K Number
    K051728
    Device Name
    MODIFICATION TO SHOULDER FIXATION SYSTEM
    Manufacturer
    HAND INNOVATIONS, LLC.
    Date Cleared
    2005-07-20

    (23 days)

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

    HAND INNOVATIONS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.
    Device Description
    The Modified Shoulder Fixation System is a set of orthopedic plates and fasteners supplied in a sterilization tray together with several reusable and disposable tools. The set of orthopedic plates and fasteners provided in the sterilization tray consists of the following implantable devices: • Shoulder Plates • Multidirectional and 90° Lock Screws • 90° Set Screws • Pegs Also, provided in the sterilization tray are the re-useable instruments
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