Search Filters

Search Results

Found 5 results

510(k) Data Aggregation

    K Number
    K220285
    Device Name
    PINE Pedicle Screw System
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2022-05-19

    (107 days)

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

    TDM Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PINE Pedicle Screw System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute or chronic spinal instabilities or deformities in the thoracic, lumbar, and sacral spine: - Degenerative disc disease (DDD) as defined by back pain of discogenc origin with degeneration of the disc confirmed by patient history and radiographic studies - Spondylolisthesis - Trauma (i.e., fracture or dislocation) - Spinal stenosis - Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) - Tumor - Pseudoarthrosis - Failed previous fusion
    Device Description
    The PINE Pedicle Screw System is a top-loading multiple component, posterior spinal fixation system which consist of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. The implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F136. Various sizes of these implants are available.
    Ask a Question
    K Number
    K191057
    Device Name
    Park's Pectus System
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2020-03-19

    (332 days)

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

    TDM Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Park's Pectus System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities
    Device Description
    Park's Pectus System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest. This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity. Park's Pectus System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.
    Ask a Question
    K Number
    K190391
    Device Name
    TDM Plate and Screw Systems
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2019-11-15

    (269 days)

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

    TDM Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The Small Locking Plate and Screw System is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, and fibula.
    Device Description
    The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical or cancellous, from 1.5mm to 4.0mm in diameter and range from 6mm to 100mm in lenath.
    Ask a Question
    K Number
    K190830
    Device Name
    TDM Screw Systems
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2019-09-13

    (165 days)

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

    TDM Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TDM Screw Systems are indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of bones appropriate for the size of the device. Cannulated Screw System: The Cannulated Screw System is intended to be used for fracture of the hand or foot (2.5mm) or small and large bones (4.0mm larger). Headless Compression Cannulated Screw System: The Headless Compression Cannulated Screw System is intended to be used for a wide range of different indications in the hand, wrist and joint fusion (arthrodeses) in the foot (2.3mm & 4.0mm) and fixation of intraarticular fractures of the humerus. femur and tibia (3.5mm & 5.0mm). Limited Sliding Screw System: The Limited Sliding Screw System is intended to be used for fracture fixation of the proximal femur, large bones and large bone fragments.
    Device Description
    The TDM Screw Systems consist of a family of devices intended for internal bone fixation of fractures, fusions, osteotomies, non-unions, and malunions. The subject devices are constructed from Titanium alloy (ASTM F136) and are comprised of cannulated screws, headless compression cannulated screws, limited sliding screws, compression screws, and washers. The subject devices are available in diameters ranging from 2.5mm to 7.5mm and lengths ranging from 10mm to 120mm. The Washer is available in 5.5mm to 13mm. The Screws are intended for standalone use.
    Ask a Question
    K Number
    K171808
    Device Name
    TDM Plate and Screw System
    Manufacturer
    TDM Co. Ltd.
    Date Cleared
    2018-03-15

    (269 days)

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

    TDM Co. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Mini and Mid Locking Plate and Screw System: The Mini and Mid Locking Plate and Screw System is intended to be used in the hands, wrist, and small bones in the foot. Small Locking Plate and Screw System: The small locking plate and screw system is indicated for the clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, fibula and other small bones. The TDM Screws (1.5mm and larger, solid) are intended to be used with the plate for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur and fibula.
    Device Description
    The TDM Plates and Screw System consists of a family of flat and contoured plates and screws that make up the Mini and Mid Locking Plate and Screw System and the Small Locking Plate and Screw System. The Plates are constructed from Titanium alloy (Ti-6AL-4V) or pure Titanium (Ti) and come in a variety of configurations. The Plates are intended to be used with solid locking and non-locking screws and non-locking low profile Screws. The Screws are constructed from titanium alloy (Ti-6AL-4V) and are available as threaded locking screws, cortical, or cancellous from 1.5mm to 4.0mm in diameter and range from 6mm to 70mm in length.
    Ask a Question

    Page 1 of 1