FDA product code KWE: Prosthesis, Finger, Constrained, Metal, Uncemented
KWE is the FDA product code for prosthesis, finger, constrained, metal, uncemented. It is a Class III device, regulated under 21 CFR 888.3200 and reviewed by the Orthopedic panel. Devices under KWE reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
call for pmas to be filed by 12/26/96 per 61 FR 50709 on 9/27/96
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Finger, Constrained, Metal, Uncemented |
| Device class | Class III |
| Regulation | 21 CFR 888.3200 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KWE devices
openFDA lists no recalls for product code KWE.
Frequently asked questions
What is FDA product code KWE?
KWE is the FDA product code for prosthesis, finger, constrained, metal, uncemented. It is a Class III device, regulated under 21 CFR 888.3200 and reviewed by the Orthopedic panel.
What device class is KWE?
Class III, regulation 21 CFR 888.3200. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KWE
- Run a recall and safety report across every KWE manufacturer
- Watch product code KWE 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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