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510(k) Data Aggregation
K Number
K211892Device Name
ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)
Manufacturer
ARFTX Medical LLC
Date Cleared
2022-10-06
(472 days)
Product Code
MQP, PLR
Regulation Number
888.3060Why did this record match?
Applicant Name (Manufacturer) :
ARFTX Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ESPINAX CORPECTOMY CAGE is intended for use in skeletally mature patients in the cervical spine (C2-T1) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The DISTRACTANIA CORPECTOMY CAGE is intended for use in skeletally mature patients in the thoracolumbar spine (T1-L5) to replace a collapsed, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
The ESPINAX and DISTRACTANIA CORPECTOMY CAGES are intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material is optional.
Device Description
The ARTFX CORPECTOMY CAGE includes product range for cervical and lomber applications.
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE-ANGLED
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE-ANGLED is used in lumber spine (T1-L5)
ESPINAX SPINAL CERVICAL CORPECTOMY CAGE is used in cervical spine (C2- T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
DISRACTANIA SPINAL LUMBAR CORPECTOMY CAGE is used , in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectorned to achieve decompression of the spinal cord and neural tissues in degenerative disorders.
ARTFX CORPECTOMY CAGE consisting of two parts, can easily be placed between the vertebra are the features to be distraction. Product is available in the cervical and lumbar spine, the upper and lower vertebrae, providing one to one contact with the angled surface. With gear structure with full contact surfaces of vertebrae forming the product surface, providing a tighter grip, eliminating the risk of slipping. Distraction prior to graft area at that provide a locking device which has a single-stage system after distraction.
The ARTFX CORPECTOMY CAGE, vertebral structure is used in cases where a portion or all of the damage. This damages the vertebral structure, tumors, fractures, and infections may occur due to.
The ARTFX CORPECTOMY CAGE is supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ISO 5832-2 and ASTM F136 .Various sizes of these components are available.
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