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©2018 Innovasis Inc.
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Innovasis, Inc.
614 East 3900 South
Salt Lake City, UT 84107 U.S.A.
Tel +1.801.261.2236
Toll Free (US) (877) 261.2236
Fax +1.801.261.0573
www.innovasis.com
Excella III-D
®
Spinal Deformity System
–
Instructions for Use
The Innovasis
®
Excella
®
Spinal System is
intended for use
in the non-cervical area of the spine.
Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals
and surgery sites equipped to perform spinal surgery.
The
Excella III-D
®
Spinal Deformity System
is designed for spinal fixation procedures in skeletally mature patients
performed through a posterior or anterolateral approach, and is intended to assist in the temporary stabilization of
spinal segments in order to provide an optimal environment for spinal fusion in the thoracolumbar region
Indications for use
are as follows:
The Innovasis
Excella III-D Spinal Deformity System
, when used as a posterior pedicle screw 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 the thoracic,
lumbar and sacral spine:
•
Degenerative disc disease (DDD
—defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies)
•
Degenerative spondylolisthesis with objective evidence of neurologic impairment
•
Scoliosis
•
Fracture or dislocation
•
Kyphosis
•
Spinal tumor
•
Pseudoarthrosis and failed previous fusion
The Innovasis
®
Excella III-D
®
Spinal Deformity System
, is also indicated for treatment of severe spondylolisthesis
(Grades 3 & 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.
When used as a posterior non-pedicle screw fixation system, the Innovasis
Excella III-D Spinal Deformity System
is intended for the treatment of:
•
Degenerative disc disease (DDD
—defined as discogenic back pain with degeneration of the disc
confirmed by history and radiographic studies)
•
Spinal stenosis
•
Spondylolisthesis
•
Spinal deformities (
i.e.
, scoliosis, kyphosis, and/or lordosis, Scheuermann’s disease)
•
Fracture
•
Pseudoarthrosis
•
Tumor resection
•
Failed previous fusion.
Overall levels of fixation are T1-sacrum/ilium.
