Spinal Fixation System
The Spinal Fixation System is an orthopedic implant device used for stabilization of the posterior thoracic and lumbar spine, typically consisting of rods, screws, hooks, and connecting elements that are surgically implanted to provide rigid fixation of vertebral segments in conditions such as spinal deformity, fracture, or degenerative disease. It is currently unclassified (device class N) with no regulation number assigned, reviewed under the Orthopedic panel. It is flagged as an implant, reflecting its use as a permanently implanted spinal stabilization construct. Unclassified devices require a De Novo or 510(k) determination before marketing in the US.
Basic Information
- Product Code
- PWG
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 3
Device Characteristics
Definition
Stabilization of the posterior thoracic and lumbar spine
Unclassified Reason
3
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.