Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K052576
    Device Name
    SBI AUTOFIX
    Manufacturer
    SMALL BONE INNOVATIONS, LLC
    Date Cleared
    2005-11-07

    (49 days)

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

    SMALL BONE INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SBi AutoFIX Twin Pitch Cannulated Compression Screw System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small bones.
    Device Description
    The SBI AutoFix™ System consists of a series of Cannulated and Non-Cannulated bone screws varying in length and diameter. The SBI AutoFix™ System is intended for use on selected fractures in the body as medically indicated and bone mass compatible.
    Ask a Question
    K Number
    K051747
    Device Name
    SBI WRISTFIT
    Manufacturer
    SMALL BONE INNOVATIONS, LLC
    Date Cleared
    2005-09-06

    (69 days)

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

    SMALL BONE INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SBI WristFIT™ (Fracture In Tension) Distal Radius System implants are indicated in the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotomies geared towards a functionally stable osteosynthesis in small and long bones. This includes: - . distal radius fractures - t distal ulna fractures - . radial osteotomies - . radial fusions - . tarsal fractures
    Device Description
    The system features non-sterile stainless steel plates with cortical locking, non-locking, and Cannulated screws in two diameters (2.4mm and 2.7mm), high angle screws with low profile heads when inserted into specially designed screw holes at angles as high as 60° to 70° off perpendicular, or 30° to 70° from the plate or bone axis, and the instruments with which to implant them.
    Ask a Question
    K Number
    K051605
    Device Name
    SBI K-WIRES
    Manufacturer
    SMALL BONE INNOVATIONS, LLC
    Date Cleared
    2005-08-10

    (55 days)

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

    SMALL BONE INNOVATIONS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SBI K-Wires are indicated for use in fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants.
    Device Description
    SBI K-Wires are provided non-sterile. They range in diameter from 0.9mm - 2.0mm and are 150mm long. They are available in single point, double point, and threaded single point.
    Ask a Question

    Page 1 of 1