Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K232394
    Device Name
    Internal Locking Plate and Screw Fixation System
    Date Cleared
    2023-12-15

    (128 days)

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

    Changzhou Geasure Medical Apparatus and Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Internal Locking Plate and Screw Fixation System is intended for temporary fixation, correction or bones in various anatomical regions. 3.5mm LCP Clavicle Plate is indicated for fixation of fractures, malunions, and osteotomies of the clavice. LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone. 3.5mm LCP Distal Humerus plate is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus. 2.4 mm LCP Volar Distal Radius Plate is indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. 5.0 LCP Distal Femur Plate is indicated for buttressing multifragmentary distal femur fractures including; supracondylar, intra-articular and extra-aticular condylar, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur. 3.5mm LCP Medial Proximal Tibia Plate is indicated to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia and tibia shaft. 3.5mm LCP Anterolateral Distal Tibia Plate is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone. 2.7mm/3.5mm LCP Distal Fibula Plate is indicated for fractures, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone. 2.0mm LCP condylar Plate is indicated for fixation of fractures, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle. The 3.5mm Round Hole Reconstruction Locking Plates is indicated for fixation of fractures, osteotomies and non-unions of the pelvis, particularly in osteopenic bone for adult patients.
    Device Description
    Internal Locking Plate and Screw Fixation System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery. Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The Internal Locking Bone Plate and Screw Fixation System is divided into four types: large, small, mini, and reconstruction. The length of the plate varies from 45 to 316mm, and hole number from 3 to 22 holes. Geasure Internal Locking Bone Screw System is used either to fasten plates or similar devices onto bones or to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their function, their size, and the type of bone they are intended for. There are two styles: locking screw, cortex or cancellous screw. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 2.0 to 6.5mm, total length from 6 to 120mm. Internal Locking Plate and Screw Fixation System is a construct in which the screws are locked in the plate. The heads of the locking screws contain male threads while the holes in the plates contain female thread, this allows the screw head to be threaded into the plate. Various plate designs are available depending on specific anatomic locations, these may be larger or smaller, thicker or thinner as appropriate to various anatomic sites and the loads to which they will be subjected. The holes in the plate are designed for locking screws, or locking and non-locking screws combination to facilitate dynamic compression. By combining locking screw holes with compression screw slots in the shaft, the plate can be used as both a locking device and a fracture compression device. Internal Locking plate and screw Fixation systems do not disrupt the underlying cortical bone perfusion as much as conventional plates, which compress the plate to the cortical bone.
    Ask a Question

    Ask a specific question about this device

    K Number
    K230456
    Device Name
    SGM Femoral Nail System
    Date Cleared
    2023-06-30

    (129 days)

    Product Code
    Regulation Number
    888.3020
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Geasure Medical Apparatus and Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    SGM Femoral Nail System is intended to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, and combinations thereof. The long SGM Femoral Nail is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.
    Device Description
    An intramedullary fixation nail is a metal rod implanted into the medullary cavity of a bone to treat fractures that occur in long bones of the body. SGM Femoral Nail System consists of a series of metal rods, proximal helical blades, bone locking bolts and end caps. The rods are cannulated and are provided with screw holes to accommodate screws of various diameters and lengths. The rods are available in a range of sizes used for specific anatomic locations and fracture configurations. The implantable devices are manufactured from titanium alloy and are provided non-sterile.
    Ask a Question

    Ask a specific question about this device

    K Number
    K223776
    Device Name
    PEEK Spinal Infusion Cage
    Date Cleared
    2023-03-03

    (77 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    Changzhou Geasure Medical Apparatus and Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The PEEK Spinal Fusion Cage is indicated for interbody fusion with autogenous bone graft in patients with Degenerative Disc Disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.These implants are to be used with autogenous bone graft. The PEEK Spinal Fusion Cage may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via an transforaminal approach. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.
    Device Description
    The PEEK Spinal Fusion Cage consists of INVIBIO PEEK-OPTIMA LTI lumbar cages of various lengths and heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow geometry of the implants allows them to be packed with autogenous bone graft.The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The implants are single-use and non-sterile provided.
    Ask a Question

    Ask a specific question about this device

    K Number
    K222031
    Device Name
    Spinal Inner Fixation System
    Date Cleared
    2022-10-28

    (109 days)

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

    Changzhou Geasure Medical Apparatus and Instruments Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Spinal Inner Fixation System is intended for posterior, non-cervical, pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.
    Device Description
    The Spinal Inner Fixation System is a medical device system for surgical fixation of the spine. It is made up of pedicle screws, set screw, rods and cross connecting devices. The implanted parts confer stabilization and fusion of two or more spinal segments and are to be removed once their stabilizing function is no longer required. The implants are single-use. The surgical instruments may be reprocessed and re-used. The Spinal Inner Fixation System includes model GB1Z-I and GB1Z-II according to the rod diameter, and each model comprises of different length rods, various length and diameter screws, set screws and accessories. Both models are designed for internal posterior thoracolumbar fixation of the spine. Patient diagnosis and individual conditions should be taken into consideration when selecting the surgical option. Surgical instruments are provided with the device system.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1