Spinal Non-Fusion Device Is An Excellent Minimally Invasive Treatment Option For Degenerative Disc Disease
Spinal Non-Fusion Device |
A Spinal Non-Fusion Device is a medical
device used to treat degenerative disc disease. This device is a non-surgical
treatment that allows the patient to return to normal activities without
experiencing significant pain. The non-fusion device can also improve the
overall quality of life by reducing hospital recovery time and allowing
patients to resume their normal activities after surgery.
A Spinal
Non-Fusion Device is a
minimally invasive treatment option that uses flexible materials to stabilize
the spine. By stabilizing the joint using a push-pull mechanism, the Non-Fusion
Device allows the vertebrae to retain a more natural position. The procedure
generally takes a few hours and is a viable alternative to traditional fusion
surgery. Patients experience immediate pain relief and reduced recovery time.
The procedure is
minimally invasive and requires no hospital stay and is done under local
anesthesia and mild sedation. In addition to its minimally invasive nature, the
Spinal Non-Fusion Device has limited
clinical efficacy and is not covered by most insurance companies.
The spinal
sphere device is a solid, spherical device made of metallic or polymeric
materials. It is inserted into the intervertebral body space of the lumbar
spine. It provides stabilization and promotes intervertebral body fusion. It is
usually used in conjunction with a bone graft material. The FDA is recommending
that Spinal Spheres be regulated under Class III of the FD&C Act. The device
is currently a Class II preamendments device and requires premarket
notification (PMA). The FDA has a proposed rule to classify the device as Class
III. The FDA first considered spinal spheres as a class III medical device in
2012. The study examined the safety of the device. The FDA evaluated the
potential risks associated with the device by reviewing data from the 2013
Orthopaedic and Rehabilitation Panel meeting and the MAUDE database.
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