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510(k) Data Aggregation

    K Number
    K182171
    Device Name
    SMV Scientific K-Wire and Pins
    Manufacturer
    Summit MedVentures
    Date Cleared
    2018-10-25

    (76 days)

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

    Summit MedVentures

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Devices (K-Wires and Steinmann Pins) are intended to be used as: - · Guide wires for osteosynthesis implants - · Accessories for external fixation (Steinmann Pins) - · Implants according to principles of fracture management
    Device Description
    The SMV Scientific K-Wire and Pin consists of K-Wire and Pins in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided nonsterile. All devices are manufactured from medical grade Stainless Steel or Titanium alloys.
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    K Number
    K150188
    Device Name
    SMV Scientific 4.5 mm Bone Screws
    Manufacturer
    SUMMIT MEDVENTURES
    Date Cleared
    2015-04-29

    (92 days)

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

    SUMMIT MEDVENTURES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SMV Scientific 4.5mm Bone Screws are intended to treat fractures of various bones including the clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).
    Device Description
    The SMV Scientific 4.5mm Solid Bone Screws consist of cortical screws in a variety of lengths to accommodate different anatomic sizes of patients. The screws are provided non-sterile and are self-tapping. Screws are manufactured from stainless steel.
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