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510(k) Data Aggregation
K Number
K080258Device Name
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2008-03-10
(39 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Device Description
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
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K Number
K073510Device Name
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2008-02-11
(60 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endius TiTLE 2® Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Endius TiTLE 2° Poly Axial 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, and failed previous fusion (pseudoarthrosis).
The Endius TiTLE 2® Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
The Endius TiTLE 2® Poly Axial Spinal System can also be linked to the Minit Posterior Cervical and Upper Thoracic Fixation System.
Device Description
The proposed Endius TiTLE 2% Poly Axial Spinal System is a system that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.
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K Number
K073267Device Name
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2008-01-30
(71 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Device Description
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium alloy that complies with ASTM F136.
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K Number
K072840Device Name
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2007-12-07
(64 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K070282Device Name
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2007-09-06
(220 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.
Axial and Offset Rod Connectors
The Minit Posterior Cervical and Upper Thoracic Fixation System can also be linked to the TiTLE and TiTLE2 Polyaxial Spinal Systems offered by Endius Inc. using the Axial Rod Connectors, Dual Rod Connectors and the Tri Screw Dual Rod Connectors.
Device Description
The proposed Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
Ask a Question
K Number
K070367Device Name
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2007-04-12
(63 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endius TiTLE 2 Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Endius TiTLE 20 Poly Axial 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, and failed previous fusion (pseudoarthrosis).
The Endius TiTLE 2 Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, the Endius TiTLE 2® Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
Device Description
The proposed Endius TiTLE 2® Poly Axial Spinal System that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.
Ask a Question
K Number
K061345Device Name
MODIFICATION TO ENDIUS ATAVI SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2006-06-06
(22 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endius Atavi System is indicated for use for posterior access and visualization in the surgical area of cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi system would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
Device Description
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The visualization components of the system include: an endoscope, a light source, light guide, a camera control unit, and a camera head.
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K Number
K060990Device Name
ENDIUS TITLE 2 POLY AXIAL SPINAL SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2006-04-26
(16 days)
Product Code
NKB, KWP, MNH, MNI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endius TiTLE 2 Poly Axial Spinal System is indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). Levels of fixation are for the thoracic, lumbar, and sacral spine.
The Endius TiTLE 2 Poly Axial 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, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Endius TiTLE 2 ° Poly Axial Spinal System is also indicated for pedicle screw fixation for severe spondylolithesis (grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.
In addition, the Endius TiTLE 2 Poly Axial Spinal System, when not used with pedicle screws is indicated for hook, wire, and/or sacral screw fixation from T1 to the ilium sacrum. The nonpedicle screw indications are spondylolithesis, degenerative disc disease, (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture, and previous failed fusion surgery.
Device Description
The proposed Endius TiTLE 2® Poly Axial Spinal System that is intended to be used for posterior lumbar fusion procedures. The system is manufactured from titanium which complies with ASTM F136. The components, which are included as part of the system, include screws, rods, and connection components.
Ask a Question
K Number
K060683Device Name
ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2006-04-18
(34 days)
Product Code
KWP
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the Endius Minit Posterior Cervical and Upper Thoracic Fixation System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.
Screws/Connectors
The use of screws is limited to placement in the T1-T3 in treating thoracic conditions only, Screws are not intended to be placed in the cervical spine.
Device Description
The Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior system, which consists of a variety of sizes of rods, hooks, screws, multi-axial screws and connecting components, which can be rigidly locked to the rod in a variety of configurations. The Minit System is fabricated from medical grade titanium or titanium alloy that complies with ASTM F136.
Ask a Question
K Number
K053267Device Name
ENDIUS ATAVI SYSTEM
Manufacturer
ENDIUS, INC.
Date Cleared
2006-01-13
(51 days)
Product Code
HRX
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
ENDIUS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endius Atavi System is indicated for use for posterior or anterior access and visualization in the surgical area of the cervical, thoracic, or lumbar spine allowing the surgeon to perform any type of surgical spinal procedures such as discectomy, nucleotomy, spinal fusion, spinal decompression, and insertion of spinal implants. Other examples of generic surgical use of the Endius Atavi™ System would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
Device Description
The Endius Atavi System includes instruments used to access the spine by dilation of the overlying tissues, as well as a retracting device that is used to maintain the access. The overying tobace, as were of the system include, an endoscope, a light source, light guide, a camera control unit, and a camera head.
Ask a Question
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