The PITBULL® system is intended to be used to help provide immobilization
and stabilization of spinal segments as an adjunct to fusion of the thoracic,
lumbar, and/or sacral spine.
The PITBULL® is a posterior, non-pedicle supple-mental fixation device intended
for use with an interbody cage as an adjunct to fusion at a single level
in the lumbar spine (LI - SI). It is intended for attachment to the spinous
processes for the purpose of achieving stabilization to promote fusion in
patients with degenerative disc disease -defined as back pain of discogenic
origin with degeneration of the disc confirmed by history and radiographic
studies -with up to Grade 1 spondy- lolisthesis.
Note Due to device placement between the spinous processes,
there is a risk for spinous process fracture or other adverse event
at the device interface with the spinous process.