Device Dossier
Fixation device, internal, spine, construct
Device Dossier for Fixation device, internal, spine, construct (Fixation device, internal, spine, construct, Class IIb, sponsor Orthopediatrics AUS).…
- GMDN category: Fixation device, internal, spine, construct
Intended purpose
Intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, including: Spinal trauma surgery, used in sublaminar, or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions. Used in conjunction with other medical implants made of titanium alloy or CoCr alloy whenever "wiring" may help secure the attachment of other implants.