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510(k) Data Aggregation

    K Number
    K070891
    Device Name
    ALTIVA CLASSIC ACP SYSTEM
    Manufacturer
    ALTIVA CORP.
    Date Cleared
    2007-06-11

    (73 days)

    Product Code
    KWQ
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTIVA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: - degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies), - spondylolisthesis, ● - trauma (i.e. fractures or dislocations), . - tumors, . - deformity (defined by kyphosis, lordosis, or scoliosis), . - pseudoarthrosis, and . - failed previous fusion. .
    Device Description
    The Altiva Classic ACP System is an anterior screw fixation system for the cervical spine. It includes titanium alloy plates and screws which are provided clean and non-sterile. Various sizes of the implants are provided.
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    K Number
    K061482
    Device Name
    ALTES BUTTRESS PLATING SYSTEM
    Manufacturer
    ALTIVA CORP.
    Date Cleared
    2006-07-26

    (57 days)

    Product Code
    KWQ, DEV
    Regulation Number
    888.3060
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALTIVA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
    Device Description
    The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.
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    K Number
    K053070
    Device Name
    CONTOUR II SPINAL SYSTEM
    Manufacturer
    ALTIVA CORP.
    Date Cleared
    2006-02-13

    (104 days)

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

    ALTIVA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTOUR II™ Spinal System is intended for noncervical, pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, the CONTOUR II™ Spinal System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion. The CONTOUR II™ Spinal System (KWP) is also intended for use as a posterior noncervical, nonpedicle system indicated for degenerative disc disease which is defined as back pain of dicogenic origin with degeneration of the disc confirmed by history and radiographic studies. spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor, pseudoarthosis, or revision of failed fusion attempts. When used as an anterior fixation system, the CONTOUR II™ Spinal System (KWO) is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, lordosis, tumor. pseudoarthosis, or revision of failed fusion attempts.
    Device Description
    The CONTOUR II™ Spinal System is an anterior / posterior spinal fixation system consisting of pedicle screws, L and straight connecting rods as well as a variety of clamps and cross connectors. The CONTOUR II™ implant components are fabricated from Ti-6AI-4V ELI per ASTM F 136. Various sizes of these implants are available.
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    K Number
    K051044
    Device Name
    ARCTEC SEMIRIGID PLATING SYSTEM
    Manufacturer
    ALTIVA CORP.
    Date Cleared
    2005-10-07

    (165 days)

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

    ALTIVA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ArcTecTM Semi-Rigid Plating System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurological impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the ArcTec™ Semi-Rigid Plating System is intended for skeletally mature patients with severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.
    Device Description
    The ArcTec™ Semi-Rigid Plating System includes plates, bolts, washers and locking nuts in addition to standard surgical instrumentation. The semi-rigid low profile plate has a low stiffness and is easy to contour. The patent pending washer design incorporates a unique polyaxial bandclamp feature that allows unlimited range of placement on the plate and screw angulation of up to 10 degrees in any plane. The system combines the simplicity of a plate with the adaptability of a polyaxial screw connection.
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    K Number
    K051216
    Device Name
    HYDRALOK SYSTEM
    Manufacturer
    ALTIVA CORP.
    Date Cleared
    2005-07-19

    (68 days)

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

    ALTIVA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HydraLok System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine including degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis) In addition, when used as a pedicle screw fixation system, the HydraLok System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft only having the device attached to the lumbar and sacral spine (L3 and below), who are having the device removed after the development of a solid fusion.
    Device Description
    The HydraLok System is a top-loading spinal fixation system including screws, rods, and connectors. The titanium alloy components are provided clean and non-sterile. Various sizes of the implants are provided.
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