May 06, 2008 - Scient'x, a privately held manufacturer of innovative spinal implant technologies, announced that it has received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL-Rod® which received FDA 510(k) clearance in 1998. The Isobar Duo™ has been cleared 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 neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion. The development of this system originated directly from surgeon requests to utilize the Isobar Dynamic TTL-Rod® technology at multiple levels. With the Isobar Duo™, the surgeon is able to utilize a standard 5.5mm diameter rod with two unique dampener elements that provides controlled motion for use at two levels... Scient'x's Press Release -
Showing posts with label Scient'x. Show all posts
Showing posts with label Scient'x. Show all posts
Tuesday, May 20, 2008
Scient'x : FDA 510(K) Clearance for Isobar DUO Dynamic Stabilization System
May 06, 2008 - Scient'x, a privately held manufacturer of innovative spinal implant technologies, announced that it has received FDA 510(k) clearance to market its new Isobar DUO™ Dynamic Stabilization System. This system is an extension of the original Isobar Dynamic TTL-Rod® which received FDA 510(k) clearance in 1998. The Isobar Duo™ has been cleared 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 neurological impairment; fracture, dislocation, scoliosis, kyphosis, spinal tumor; and failed previous fusion. The development of this system originated directly from surgeon requests to utilize the Isobar Dynamic TTL-Rod® technology at multiple levels. With the Isobar Duo™, the surgeon is able to utilize a standard 5.5mm diameter rod with two unique dampener elements that provides controlled motion for use at two levels... Scient'x's Press Release -
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