FDA product code KIG: Prosthesis, Wrist, Constrained, Polymer
KIG is the FDA product code for prosthesis, wrist, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3780 and reviewed by the Orthopedic panel. Devices under KIG reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Constrained, Polymer |
| Device class | Class II |
| Regulation | 21 CFR 888.3780 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for KIG devices
openFDA lists no recalls for product code KIG.
Frequently asked questions
What is FDA product code KIG?
KIG is the FDA product code for prosthesis, wrist, constrained, polymer. It is a Class II device, regulated under 21 CFR 888.3780 and reviewed by the Orthopedic panel.
What device class is KIG?
Class II, regulation 21 CFR 888.3780. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code KIG
- Run a recall and safety report across every KIG manufacturer
- Watch product code KIG 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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