FDA product code NEG: Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis
NEG is the FDA product code for finger semi-constrained pyrolytic carbon uncemented prosthesis. It is a Class III device, reviewed by the Orthopedic panel. Devices under NEG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 2 recalls for NEG devices.
Definition
Pma approved: P000057
Classification
| Field | Value |
|---|---|
| Device name | Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NEG devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-06-17.
Frequently asked questions
What is FDA product code NEG?
NEG is the FDA product code for finger semi-constrained pyrolytic carbon uncemented prosthesis. It is a Class III device, reviewed by the Orthopedic panel.
What device class is NEG?
Class III. Typical premarket route: PMA.
Have NEG devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2009-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NEG
- Run a recall and safety report across every NEG manufacturer
- Watch product code NEG 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.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times