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510(k) Data Aggregation

    K Number
    K143013
    Device Name
    Spinal Inner Fixation System
    Manufacturer
    Changzhou Dingjian Medical Appliance Co., Ltd
    Date Cleared
    2015-12-11

    (417 days)

    Product Code
    MNH, KWP, MNI
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Dingjian Medical Appliance Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Spinal inner fixation system is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.
    Device Description
    Spinal inner fixation system consists of a variety of shapes and sizes of pedicle screws, rods, hooks, transverse linking pole assembly, and connecting components (side, domino, and axial), which can be rigidly locked into a variety of configurations. These components are made of titanium alloy per ASTM F136.
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    K Number
    K143002
    Device Name
    Metallic Locking Bone Plate and Screw System
    Manufacturer
    Changzhou Dingjian Medical Appliance Co., Ltd
    Date Cleared
    2015-06-05

    (228 days)

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

    Changzhou Dingjian Medical Appliance Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Metallic Locking Bone Plate and Screw System are intents with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.
    Device Description
    The proposed device, Metallic Locking Bone Plate and Screw System consists of bone plate and screw. The bone plates are used for internal fixation of bone fracture, including ulna, radius, humerus, femur and tibia. Implant is made of Ti6Al4V Eli and titanium which conforms to ASTM F 136 and ASTM F67. The proposed devices are provided un-sterilized. They shall be sterilized prior to use by healthcare provider. The proposed devices shall never be reused.
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