SGK — Prosthesis, Spinous Process Tension Band Implant Class III
FDA product code SGK covers "Prosthesis, Spinous Process Tension Band Implant", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- SGK
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
This device is a non-fusion, tension band implant that is intended to provide dynamic flexion-restricting stabilization of the spine following a lumbar decompression.