FDA product code KWJ: Prosthesis, Elbow, Hemi-, Humeral, Metal
KWJ is the FDA product code for prosthesis, elbow, hemi-, humeral, metal. It is a Class III device, regulated under 21 CFR 888.3180 and reviewed by the Orthopedic panel. Devices under KWJ 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, Elbow, Hemi-, Humeral, Metal |
| Device class | Class III |
| Regulation | 21 CFR 888.3180 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | PMA |
| Implant | Yes |
Recalls for KWJ devices
openFDA lists no recalls for product code KWJ.
Frequently asked questions
What is FDA product code KWJ?
KWJ is the FDA product code for prosthesis, elbow, hemi-, humeral, metal. It is a Class III device, regulated under 21 CFR 888.3180 and reviewed by the Orthopedic panel.
What device class is KWJ?
Class III, regulation 21 CFR 888.3180. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code KWJ
- Run a recall and safety report across every KWJ manufacturer
- Watch product code KWJ 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.