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510(k) Data Aggregation
K Number
K191584Device Name
FORTICO Anterior Cervical Fixation System
Manufacturer
Camber Spine Technologies LLC
Date Cleared
2019-10-22
(130 days)
Product Code
KWQ
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
Camber Spine Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FORTICO Anterior Cervical Fixation System (Fortico Plate and Screws) is intended for anterior screw fixation to the cervical spine (C2-T1) in skeletally mature patients for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (such as fracture or dislocation), spinal stenosis, deformities or curvatures (such as scoliosis, or lordosis), tumor, pseudarthrosis, and failed previous fusion.
Device Description
The FORTICO Anterior Cervical Fixation System is a cervical plating system that consists of a cervical plate that includes bone screw holes and blocking mechanisms to prevent screw back-out.
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K Number
K180980Device Name
ORTHROS Posterior Stabilization System; ORTHROS MIS Posterior Stabilization System
Manufacturer
Camber Spine Technologies LLC
Date Cleared
2018-10-27
(197 days)
Product Code
NKB
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Camber Spine Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORTHROS™ MIS Posterior Stabilization System, when used in a posterior percutaneous approach is 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 thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), spinal tumor, and failed previous fusion (pseudarthrosis). In addition, ORTHROS™ MIS Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L-3sacrum/ilium.
The ORTHROS™ Posterior Stabilization System is 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 thoracic, lumbar, and sacral/iliac spine (T1-S1/Ilium): degenerative disc disease (defined as discogenic back pain with degeneration of disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). In addition, the ORTHROS™ Posterior Stabilization System is intended for treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and/or ilium with removal of the implants after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
Device Description
The ORTHROS™ Posterior Stabilization System is a multiple component, posterior stabilization system which consists of a variety of shapes and sizes of rods, monoaxial screws, polyaxial screws, cannulated polyaxial screws, reduction screws, cannulated reduction screws, locking caps, locking set screws, cross links, and associated manual surgical instruments. The ORTHROS™ Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. Polyaxial screws are intended for posterior and anterior use. Rods and monoaxial screws may be used anteriorly or posteriorly. Locking Caps and Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136.
The ORTHROS™ MIS Posterior Stabilization System is a multiple component, minimally invasive posterior stabilization system which consists of a variety of shapes and sizes of rods, cannulated percutaneous/MIS polyaxial screws, locking set screws, and associated manual surgical instruments. The ORTHROS™ MIS Posterior Stabilization System is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion in skeletally mature patients. Implant components can be rigidly locked into a variety of configurations for the individual patient and surgical condition. The MIS polyaxial screws are intended for posterior use. Locking Set Screws are used to connect the screws to the rods. All implants are composed of Titanium Alloy (TAV), as specified in ASTM F136. The ORTHROS™ MIS System also utilizes select instrumentation from the ORTHROS™ Posterior Stabilization System.
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K Number
K180724Device Name
SPIRA Open Matrix LLIF
Manufacturer
Camber Spine Technologies LLC
Date Cleared
2018-06-25
(97 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
Camber Spine Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Camber Spine Technologies SPIRA Open Matrix LLIF is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Camber Spine Technologies SPIRA Open Matrix LLIF is intended to be used with additional FDA-cleared supplementary fixation systems. The Camber Spine Technologies SPIRA Open Matrix LLIF system must be used with autogenous bone graft material.
Device Description
The Camber Spine Technologies SPIRA Open Matrix LLIF is an Interbody Fusion Device that has spiral support arches to allow for a hollow chamber to permit packing with autogenous bone to facilitate fusion. The superior and inferior surfaces of the device have a roughened surface to help prevent movement of the device while fusion takes place.
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