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510(k) Data Aggregation

    K Number
    K163363
    Device Name
    SurgTech Thoracolumbosacral (TLS) Posterior Fixation System
    Manufacturer
    SurgTech Inc.
    Date Cleared
    2017-04-05

    (126 days)

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

    SurgTech Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System is intended to provide pedicle and non-pedicle immobilization and stabilization of the posterior non-cervical spine (T1-S2/Ilium) in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: 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.
    Device Description
    The SurgTech Thoracolumbosacral (TLS) Posterior Fixation System consists of longitudinal members (rods), anchors (hooks and screws), interconnections (cross connector) and fasteners in a variety of sizes to accommodate differing anatomic requirements.
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    K Number
    K161894
    Device Name
    SurgTech Trauma System
    Manufacturer
    SURGTECH INC
    Date Cleared
    2017-02-21

    (225 days)

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

    SURGTECH INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgTech Trauma System plates and screws are intended to be used for internal bone fixation for bone fractures, fusions, osteotomies and non-unions appropriate for the size and design of the device. The large plate set components are indicated for the use including the femur and tibia. The small plate set is indicated for use in various bones including the clavicle, scapula, humerus, radius, ulna, pelvis, tibia and fibula. The mini plate set is indicated for use in various small bones including the metacsals, phalanges, calcaneus and those of the ankle. In addition, the SurgTech Trauma System cancellous, cannulated lag, headless compression and non-locking cortical screws are indicated for use in bone reconstruction, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.
    Device Description
    The SurgTech Trauma System is a plate and screw fixation system. Plates are offered in "mini," "small" and "large" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" "small" and "large" sets and, in addition, in locking cortical, non-locking cortical, cancellous and headless versions. Screws can also be used for fixation without the plates.
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    K Number
    K152200
    Device Name
    SurgTech Interbody System
    Manufacturer
    SURGTECH INC
    Date Cleared
    2016-03-25

    (232 days)

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

    SURGTECH INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SurgTech Interbody System is indicated for use with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These patients may have had a previous non-fusion spinal surgery and may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved spinal level(s). These devices are intended to be used with supplemental fixation which has been cleared for use in the lumbar spine.
    Device Description
    The SurgTech Interbody System is a system of intervertebral body fusion devices. The Posterior Lumbar device is a structural column in a generally rectangular shape having a rounded nose. Teeth are integral to the inferior and superior surfaces and there is a central cavity to be filled with autograft. The implants are available in an assortment of footprint, height and angulation combinations to accommodate a variety of anatomic requirements.
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