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The FAVO S-TLIF Cage is indicated for intervertebral body fusion of the spine in skeletally mature patients. The system is designed for use with autogenous bone graft to facilitate fusion and supplemental internal spinal fixation systems cleared by the FDA for use in the thoracolumbar spine. The device is to be used in patients who have had at least six months of non-operative treatment.

The FAVO S-TLIF Cage is intended for use in interbody fusions at one or two contiguous levels in the thoracic spine from T1 to T12 and at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic disc degeneration (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain).

The FAVO S-TLIF Cage is intended for use at one or two contiguous levels in the lumbar spine, from L1 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The FAVO S-TLIF Cage can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.

The FAVO S-TLIF (straight transforaminal lumbar interbody fusion) Cage is an implant for primary stabilization and restoration of physiological lordosis in the lumbar and thoracic spine. The cage is designed for transforaminal approaches.

The aim is to eliminate discogenic back pain, correct deformities, remedy instabilities, restore intervertebral height, restore physiological lordosis, and provide biomechanical support for bone fusion in the disc space.

The system is designed for use with autogenous bone graft to facilitate fusion and must be used with additional stabilization. For posterior lumbar stabilization, Silony Medical recommends the use of a posterior spinal fixator (e.g., the VERTICALE system). The devices are to be used in patients who have had at least six months of non-operative treatment. The FAVO S-TLIF is manufactured from titanium alloy conforming to ASTM F136 / ISO 5832-3 and ASTM F3001.

The FAVO S-TLIF implant is delivered in a sterile condition and can be used without any further preparations. The cages are packaged in accordance with EN ISO 11607 Party 1+2 and sterilized with gamma irradiation at a minimum dose of 25 kGy.

Implants delivered by the manufacturer in a sterile condition may not be sterilized.

This document is a 510(k) Premarket Notification for a medical device called FAVO® S-TLIF, which is an intervertebral body fusion device. The document does not describe a study that uses AI or machine learning technology, so the request for acceptance criteria and study details related to an AI device cannot be fulfilled from this document.

The provided text describes the regulatory clearance of a physical medical device (intervertebral body fusion cage) and outlines its indications for use, device description, and non-clinical performance data (mechanical testing, biocompatibility, sterilization, shelf life, and transport testing). It explicitly states that no human clinical testing was required because the indications for use are equivalent to a predicate device and non-clinical testing supports substantial equivalence.

Therefore, since the request pertains to an AI device and this document is about a physical spinal implant with no mention of AI or machine learning, I cannot extract the requested information.

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