
TSRH-3D® Spinal Instrumentation -
The most recent addition to the TSRH® Spinal System family came in
1999 with the release of TSRH-3D® Spinal Instrumentation. It
consists of a connector and pedicle screw that attach to the rod
allowing intraoperative adjustments in the coronal, transverse, and sagittal
planes.
TSRH-3D® Spinal Instrumentation offers rods, screws,
set screws, and extended post screws in both titanium and stainless steel
in a variety of sizes. The instrumentation's screws offer 17 diameter
and length combinations.
Caution: Federal
law (USA) restricts these devices to sale by or on the order of a physician.
Caution: For use on
or by the order of a physician only.
See the Package Insert for labeling warnings, precautions,
and other important information.
The TSRH-3D® connectors and TSRH-3D® screws
are intended for posterior use only. When used as a pedicle screw fixation
system of the non-cervical posterior spine in skeletally mature patients,
the TSRH® Spinal System is indicated for one or more of the following:
(1) degenerative spondylolisthesis with objective evidence of neurologic
impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis,
(6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
See the TSRH® Spinal System Package Insert for a complete listing
of indications, warnings, precautions, labeling limitations and other
important information.
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