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510(k) Data Aggregation
K Number
K052406Device Name
UNI-THREAD SPINAL SYSTEM
Manufacturer
SPINE VISION, INC
Date Cleared
2005-11-07
(67 days)
Product Code
MNI, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SPINE VISION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the Uni-Thread Spinal System is a pedicle screw system intended 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:
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- fracture
- dislocation
- scoliosis
- kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis)
Device Description
The Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The Uni-Thread System components are available in titanium alloy manufactured according to ASTM-F136.
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K Number
K021507Device Name
PLUS PIVOT LINK UNIVERSAL SYSTEM
Manufacturer
SPINE VISION, INC
Date Cleared
2002-08-01
(84 days)
Product Code
KWP, MNH, MNI
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
SPINE VISION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used as a posterior, non-pedicle system of the noncervical spine, the PLUS™ Pivot Link Universal System is indicated for:
- degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
- spondylolisthesis
- fracture
- spinal stenosis
- deformities (i.e. scoliosis, kyphosis, lordosis)
- tumors
- failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;
- receive fusions using autogenous bone graft only;
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion.
In addition, the PLUS Pivot Link Universal System is a pedicle screw system intended 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:
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- fracture
- dislocation
- scoliosis
- kyphosis
- spinal tumor
- failed previous fusion (pseudoarthrosis)
Device Description
The PLUS Pivot Link Universal System spinal instrumentation consists of hooks, screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying according to the nature of the spinal pathology. The PLUS System components are available in stainless steel according to ASTMs F138 and F1586, from titanium alloy complying with ASTM-F136, and from commercially pure Titanium complying with ASTM F67.
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K Number
K021510Device Name
UNI-T UNI-THREAD SPINAL SYSTEM
Manufacturer
SPINE VISION, INC
Date Cleared
2002-08-01
(84 days)
Product Code
MNI, MNH
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
SPINE VISION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UNI-T Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:
- have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; .
- receive fusions using autogenous bone graft only; .
- have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and
- have the device removed after the development of a solid fusion. .
In addition, the UNI-T Uni-Thread Spinal System is a pedicle screw system intended 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:
- Degenerative spondylolisthesis with objective evidence of neurologic impairment ●
- fracture
- . dislocation
- scoliosis ●
- kyphosis
- spinal tumor ●
- failed previous fusion (pseudoarthrosis) ●
Device Description
The UNI-T Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that can be assembled in a variety of constructs. The instrumentation is combined and placed to treat a variety of spinal disorders, with the constructs varying to the nature of the spinal pathology. The UNI-T System components are available in titanium alloy manufactured according to ASTM-F136.
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K Number
K012881Device Name
C3 ANTERIOR CERVICAL PLATE SYSTEM
Manufacturer
SPINE VISION, INC
Date Cleared
2001-11-26
(90 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
SPINE VISION, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The C3™ Anterior Cervical Plate System is intended as a temporary internal fixation device used for the correction and stabilization of the cervical spine. The system is also intended to enhance the development of a solid fusion.
The C3™ Anterior Cervical Plate System is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The C3™ Anterior Cervical Plate System is also indicated for stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Device Description
The C3™ Anterior Cervical Plate System is a titanium alloy anterior cervical plate fixation system. The system consists of a number of plates and screws of varying lengths and a variety of cover plates with locking set screws. Screws are available in different diameters, several lengths, and two different styles: fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws.
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