FDA product code KWO: Prosthesis, Wrist, Carpal Scaphoid
KWO is the FDA product code for prosthesis, wrist, carpal scaphoid. It is a Class II device, regulated under 21 CFR 888.3760 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under KWO. The average 510(k) review took 153 days (median 153).
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Wrist, Carpal Scaphoid |
| Device class | Class II |
| Regulation | 21 CFR 888.3760 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every KWO clearance
Top KWO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dow Corning Wright | 1 | 1987-04-15 |
Most recent KWO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K864490 | Dow Corning Wright | SWANSON TITANIUM CARPAL SCAPHOID IMPLANT | 1987-04-15 | 153 |
Recalls for KWO devices
openFDA lists no recalls for product code KWO.
Frequently asked questions
What is FDA product code KWO?
KWO is the FDA product code for prosthesis, wrist, carpal scaphoid. It is a Class II device, regulated under 21 CFR 888.3760 and reviewed by the Orthopedic panel.
What device class is KWO?
Class II, regulation 21 CFR 888.3760. Typical premarket route: 510(k).
How long does a 510(k) take for product code KWO?
Across 1 cleared submissions the average was 153 days from receipt to decision (median 153).
Which companies have the most KWO clearances?
Dow Corning Wright (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KWO
- Run a recall and safety report across every KWO manufacturer
- Watch product code KWO 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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