Prosthesis, Spinous Process Spacer/Plate
The spinous process spacer and plate prosthesis is an orthopedic implant placed between or attached to the spinous processes of the vertebrae to provide stability, decompress neural elements, or limit spinal extension in the treatment of spinal stenosis or degenerative conditions. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) due to the novel and high-risk nature of spinal implantation. Product code NQO carries an implant flag and is reviewed by the Orthopedic panel.
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Basic Information
- Product Code
- NQO
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
This device is an interspinous spacer or spinous process plate that is implanted between the spinous processes or attached to the spinous process.
FEI Numbers
This FDA classification entry is associated with 23 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 23 registration numbers. Click on an entry to view related FDA registrations.