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510(k) Data Aggregation

    K Number
    K130185
    Device Name
    4WEB OSTEOTOMY BONE WEDGE
    Manufacturer
    4-WEB, INC.
    Date Cleared
    2013-06-07

    (133 days)

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

    4-WEB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4Web Osteotomy Bone Wedge is intended to be used for internal bone fixation on osteotomies in the foot, such as: 1. Opening wedge osteotomies of Hallux Valgus 2. Cotton opening wedge osteotomies 3. Evans lengthening osteotomies These devices are intended to be used with autograft bone and ancillary fixation. The 4Web Osteotomy Bone Wedge is not intended for use in the spine.
    Device Description
    The 4Web Osteotomy Bone Wedge is a titanium alloy implant used for correction of small bones in the foot. It is offered in two shapes and multiple sizes for each shape with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4-Web truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.
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    K Number
    K121741
    Device Name
    4-WEB CERVICAL STS (SPINAL TRUSS SYSTEM)
    Manufacturer
    4-WEB, INC.
    Date Cleared
    2012-10-18

    (127 days)

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

    4-WEB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 4-Web Cervical Spinal Truss System (STS) is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. Th DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. 4-Web Cervical STS implants are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.
    Device Description
    The Cervical STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in two basic "footprint" sizes, 17mm x 14mm x 11mm. These sizes are available in zero and 7 degree lordosis and each of these in 8 heights ranging from 5mm to 12mm in 1mm increments.
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    K Number
    K112316
    Device Name
    4-WEB ALIF SPINAL TRUSS SYSTEM (STS)
    Manufacturer
    4-WEB, INC.
    Date Cleared
    2011-12-14

    (125 days)

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

    4-WEB, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALIF Spinal Truss Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation and must be used with autograft bone. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).
    Device Description
    The ALIF STS Interbody Fusion Device is a titanium implant that is designed to provide mechanical support to the lumbar spine while biologic fusion takes place. The device is an "open architecture" design consisting of trusses mathematically designed to provide maximum support with the greatest amount of open space throughout the implant for bone growth and fusion. The implant is made from Ti6Al4V alloy. The device is available in three basic "footprint" sizes, small, medium and large. These sizes are available in 0, 6, 8 and 12 degree lordosis and each of these in 9 heights ranging from 8mm to 17mm in 1mm increments.
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