FDA product code SGK: Prosthesis, Spinous Process Tension Band Implant
SGK is the FDA product code for prosthesis, spinous process tension band implant. It is a Class III device, reviewed by the Orthopedic panel. Devices under SGK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Spinous Process Tension Band Implant |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for SGK devices
openFDA lists no recalls for product code SGK.
Frequently asked questions
What is FDA product code SGK?
SGK is the FDA product code for prosthesis, spinous process tension band implant. It is a Class III device, reviewed by the Orthopedic panel.
What device class is SGK?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code SGK
- Run a recall and safety report across every SGK manufacturer
- Watch product code SGK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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