Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K062391
    Device Name
    DISPOSABLE POSTERIOR LUMBAR STABILIZATION PROCEDURE KIT, MODELS 9045-01 AND 9045-02; COMPRESSION TOOL, MODEL 6113-00
    Manufacturer
    TRIAGE MEDICAL, INC.
    Date Cleared
    2006-09-14

    (29 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIAGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4.5mm Facet Compression Device, which is included in the Disposable Posterior Lumbar Stabilization Procedure Kit, is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1. The intended use of the associated manual surgical instruments is to aid in the implantation of the 4.5mm Facet Compression Device.
    Device Description
    The 4.5mm Facet Compression Device(s) contained in the Disposable Posterior Lumbar Stabilization Procedure Kit is a double-helix screw with a compression-locking collar and self-retaining washer. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. Disposable surgical instruments for use in implanting the device are also included in the kit. The kit is provided "STERILE"; sterilization is by gamma radiation. The re-usable Compression Tool is provided separately in a "NONSTERILE" condition; sterilization is by moist heat (steam autoclaye) and is performed on-site.
    Ask a Question
    K Number
    K052043
    Device Name
    3.8MM CS FACET COMPRESSION DEVICE
    Manufacturer
    TRIAGE MEDICAL, INC.
    Date Cleared
    2005-10-17

    (81 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIAGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 3.8mm CS Facet Compression Device is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis and failed previous fusion. The intended use of the 3.8mm CS Facet Compression Device is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The 3.8mm CS Facet Compression Device is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1.
    Device Description
    The 3.8mm CS Facet Compression Device is a double-helix screw with a compressionlocking collar, and is provided with or without a self-retaining washer. It is available in various length ranges fabricated from either Titanium 6Al-4V, which meets the requirements of ASTM F-136 or stainless steel, which meets the requirements of ASTM F-138.
    Ask a Question
    K Number
    K051949
    Device Name
    4.5 MM LS FACET COMPRESSION DEVICE WITH POLYMER WASHER, MODEL LSPW-45-3040
    Manufacturer
    TRIAGE MEDICAL, INC.
    Date Cleared
    2005-08-05

    (21 days)

    Product Code
    MRW
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRIAGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for spondylolisthesis, spondylolysis, degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies, degeneration of the facets with instability and fracture, pseudoarthrosis or failed previous fusion. The intended use of the 4.5mm LS Facet Compression Device with Polymer Washer is to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. The screws are inserted posteriorly through the superior side of the facet, across the facet joint and into the pedicle. The 4.5mm LS Facet Compression Device with Polymer Washer is indicated for bilateral facet fixation, with or without bone graft, at single or multiple levels from L1 to S1.
    Device Description
    The 4.5mm LS Facet Compression Device is a double-helix screw with a compressionlocking collar. It is available as 4.5mm diameter device and is obtainable in a 30-40mm length range. The 4.5mm LS Facet Compression Device with Polymer Washer is intended for single use only. Devices are provided "STERILE" and are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
    Ask a Question
    K Number
    K042244
    Device Name
    BONE-LOK MVP CORTICAL-CANCELLOUS COMPRESSION DEVICE
    Manufacturer
    TRIAGE MEDICAL, INC.
    Date Cleared
    2004-09-16

    (28 days)

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

    TRIAGE MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BONE-LOK® MVP Cortical-Cancellous Compression Device is indicated for use in the general management of fractures and reconstructive surgery.
    Device Description
    The BONE-LOK® MVP Cortical-Cancellous Compression Device is a double-helix screw with a compression-locking collar. It is available as 3.5mm or 4.5mm diameter device with a compression looking ochan 1978 - The BONE-LOK® MVP Cortical-Cancellous Compression Device is intended for single use only. Devices provided "STERILE" are double-pouched in Tyvek®ffilm pouches and sterilized by gamma radiation.
    Ask a Question

    Page 1 of 1