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Found 7 results
510(k) Data Aggregation
K Number
K091995Device 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
888.3070Why 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
K091219Device 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
888.3070Why 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
K083826Device 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
888.3070Why 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
K072678Device 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
888.3070Why 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
K070460Device 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
888.3070Why 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
K051275Device 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
888.3070Why 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
K050060Device Name
LAGUNA PEDICLE SCREW SYSTEM
Manufacturer
ALLEZ SPINE, LLC
Date Cleared
2005-05-04
(113 days)
Product Code
MNI, KWP, KWQ, MNH
Regulation Number
888.3070Why 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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