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510(k) Data Aggregation

    K Number
    K223150
    Device Name
    APS Metal Plate & Screw System
    Date Cleared
    2023-08-24

    (323 days)

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

    A Plus Biotechnology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Locking Screw: The locking screws, in combination with the appropriate locking plate, are indicated for fixation of fractures, non-unions, replantations, and fusions of small bone fragments, particularly in osteopenic bone of the hand, wrist, foot, and ankle. Cortex Screw: The Cortex Screw is indicated to be used with the APS Metal Plate & Screw System for the fixatures, osteotomies, non-unions, replantations, and fusions involving small bone fragments, especially in osteopenic conditions. Examples include, but are not limited to, the hand, wrist, foot, and ankle. Star Cancellous Screw: The Star Cancellous Screw is indicated for the fixation of fractures, and non-unions involving the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, and distal tibia, fibula, particularly in osteopenic bone. APS HLR Screw: The APS HLR Screw is indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments, including joint fusions (arthrodesis) in the foot and fixation of intra-articular fractures of the humerus, femur, and tibia. Distal CAS Locking Plate: The Distal CAS Locking Plate is indicated for fixation of fractures, malunions, and osteotomies of the distal (lateral) clavicle. Distal Clavicle Hook Locking Plate | Clavicle Anatomical Midshaft Locking Plate: The Distal Clavicle Hook Locking Plate and Clavicle Anatomical Midshaft Locking Plate are indicated for the fixation of distal (lateral) clavicle fractures, mid-shaft clavicle fractures, and dislocations of the acromioclavicular joint. Distal Medial Humeral Locking Plate | Proximal Humeral Locking Plate: The Distal Medial Humeral Locking Plate and Proximal Humeral Locking Plate are indicated for fracture dislocations, osteotomies, and non-unions of the distal (medial) and proximal humerus, particularly in osteopenic bone. Small ABS Locking Plate | Dynamic Compression Locking Plate: The Small ABS Locking Plate and Dynamic Compression Locking Plate are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone. Distal Radial Locking Plate | Trident Distal Radial Locking Plate: The Distal Radial Locking Plate and Trident Distal Radial Locking Plate are indicated for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones. Distal Lateral Femoral Locking Plate: The Distal Lateral Femoral Locking Plate is indicated for buttressing distal femur fractures, including supracondylar, intra-articular and extra-articular condylar, peri-prosthetic fractures in normal or osteopenic bone, non-unions and mal-unions, and osteotomies of the femur. Large ABS Locking Plate: The Large ABS Locking Plate is indicated for fixation of various lones, such as the humerus, femur, and tibia. It is also for use in the fixation of osteopenic bone and fixation of non-unions or mal-unions. Distal FDH Locking Plate: The Distal FDH Locking Plate is indicated for fractures, osteotomies, and non-unions of the metaphyseal region of the distal fibula, especially in osteopenic bone. Distal Tibia Locking Plate System (Antero Lateral Distal Tibial Locking Plate, Distal Medial Tibial Locking Plate): The Distal Tibia Locking Plate System is indicated for fractures, and non-unions of the distal tibia, especially in osteopenic bone. Proximal Medial Tibial Locking Plate: The Proximal Medial Tibial Locking Plate is indicated for buttressing metaphyseal fractures of the medial tibial plateau, split-type fractures of the medial tibial plateau, and medial split fractures with associated depression fractures of the medial tibial plateau. Calcaneal Locking Plate: The Calcaneal Locking Plate is indicated for addressing complex of the calcaneus, including, but not limited to, extra-articular, joint depression, tongue-type, and severely comminuted fractures. Distal RAF Locking Plate: The Distal RAF Locking Plate is indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones. Mini Locking Plate System: The Mini Locking Plate System is indicated for fixation of fractures, non-unions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
    Device Description
    The APS Metal Plate & Screw System provides anatomically contoured plates designed for use with both non-locking and locking screws. These plates are equipped with locking holes as well as holes for cortex screws, enhancing compression pressure. The combination of locking and compression technologies ensures the implants provide sufficient stability. The system is provided non-sterile and is sterilized in the user facility.
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