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510(k) Data Aggregation

    K Number
    K091995
    Device Name
    LAGUNA SIZE 8 PEDICLE SCREW SYSTEM
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2009-08-07

    (36 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGUNA® Size 8 Pedicle Screw System is intended to be used as an adjunct to fusion in skeletally mature patients using autograft or allograft in posterior, non-cervical fixation for the following conditions: 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 LAGUNA® Size 8 Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The LAGUNA® Size 8 Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Polyaxial screws are supplied in winged and non-winged configurations, in a variety of different length, ranging from 35 mm to 100 mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The LAGUNA® Size 8 Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
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    K Number
    K091219
    Device Name
    DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2009-07-09

    (73 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEL MAR® Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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. The DEL MAR® Monoaxial Pedicle Screw System is intended to be used with autograft and/or allograft as an adjunct to fusion.
    Device Description
    The DEL MAR® Monoaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Monoaxial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The DEL MAR® Monoaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
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    K Number
    K083826
    Device Name
    LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2009-01-22

    (30 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGUNA® Polyaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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 LAGUNA® Polyaxial Pedicle Screw System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case Multi axial screws are supplied in winged and non-winged configurations, in a variety of different length, and in 5mm, 6mm, and 7mm diameter sizes All sizes are able to receive 5 5mm connecting rods only. The LAGUNA® Polyaxial Pedicle Screw System implant components are fabricated from medical grade titanium alloy per ASTM F136.
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    K Number
    K072678
    Device Name
    LAGUNA SIZE 8 PEDICLE SCREW
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2008-07-02

    (285 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGUNA™ Spinal System is intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical pedicle fixation for the following conditions: 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 LAGUNA™ Size 8 Pedicle Screws are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine LAGUNA™ Polyaxial Pedicle Screw System. The LAGUNA™ Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine LAGUNA™ Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The LAGUNA™ Size 8 Pedicle Screws are available in eleven sizes ranging from 30 mm to 100 mm are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
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    K Number
    K070460
    Device Name
    ALLEZ SPINE CROSS CONNECTORS
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2007-06-11

    (115 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ALLEZ SPINE Cross Connectors are intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The ALLEZ SPINE Cross Connectors are intended for posterior, non-cervical fixation in conjunction with the Allez Spine Laguna Pedicle Screw System for the following conditions: 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 ALLEZ SPINE Cross Connectors are intended to help provide and Characteristics: correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space in conjunction with the Allez Spine Laguna Polyaxial Pedicle Screw System. The Laguna Spinal System consists of a variety of rods and screws. which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The Allez Spine Laguna Polyaxial Pedicle Screw System (K050060) was cleared for marketing on May 4, 2005. The ALLEZ SPINE Cross Connectors are available in three sizes: small (37 mm), medium (50 mm) and large (80 mm) and are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
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    K Number
    K051275
    Device Name
    LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2005-12-09

    (206 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LAGUNA™ Monoaxial Pedicle Screw System is intended for posterior, non-cervical fixation for the following conditions: 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 Laguna™ Monoaxial Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. The additional monoaxial screws are supplied in winged and non-winged configurations from 30 to 80 mm length and in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
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    K Number
    K050060
    Device Name
    LAGUNA PEDICLE SCREW SYSTEM
    Manufacturer
    ALLEZ SPINE, LLC
    Date Cleared
    2005-05-04

    (113 days)

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

    ALLEZ SPINE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Laguna Spinal System is intended for posterior, non-cervical fixation for the following conditions: 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 Laguna TM Pedicle Screw System is intended to help provide correction, immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar and/or sacral space. The Laguna Spinal System consists of a variety of rods and screws, which can be rigidly locked into a variety of configurations, with each construct being tailor made for the individual case. Multi axial implant screws are supplied in 5mm, 6mm, 7mm and 8mm diameter sizes. All sizes are able to receive 5.5mm connecting rods only. The Laguna Spinal System implant components are fabricated from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3 or 5832-2.
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