VySpine was granted FDA 510(k) clearance to market the DiversiVy Facet Screw System, designed for use in the lumbosacral spine to stabilize the spine and aid in fusion.
The system is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic: Degenerative Disc Disease as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
“The DiversiVy clearance is the latest in a long line of Vy Spine implants to provide physicians with optimal options for their patients,” Bret Berry, President of Product Development for Vy Spine notes. “Vy Spine is focused on expanding our portfolio of products with an emphasis on simple and robust fixation, at a price-conscious value.”
VySpine was granted FDA 510(k) clearance to market the DiversiVy Facet Screw System, designed for use in the lumbosacral spine to stabilize the spine and aid in fusion.
The system is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft,...
VySpine was granted FDA 510(k) clearance to market the DiversiVy Facet Screw System, designed for use in the lumbosacral spine to stabilize the spine and aid in fusion.
The system is intended to stabilize the spine as an aid to fusion by transfacet fixation. The device is indicated for posterior surgical treatment with or without bone graft, at single or multiple levels, of any or all of the following spinal levels L1 to S1 (inclusive): Spondylolisthesis, Spondylolysis, Pseudoarthrosis or failed previous fusions which are symptomatic: Degenerative Disc Disease as defined by back pain of discogenic origin with degeneration of disc confirmed by history and radiographic studies and/or degenerative disease of the facets with instability.
“The DiversiVy clearance is the latest in a long line of Vy Spine implants to provide physicians with optimal options for their patients,” Bret Berry, President of Product Development for Vy Spine notes. “Vy Spine is focused on expanding our portfolio of products with an emphasis on simple and robust fixation, at a price-conscious value.”
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