FDA product code NEK: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction
NEK is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction. It is a Class III device, reviewed by the Orthopedic panel. Devices under NEK reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code. FDA has posted 8 recalls for NEK devices.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction |
| Device class | Class III |
| Review panel | OR — Orthopedic |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for NEK devices
8 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-09-27.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NEK?
NEK is the FDA product code for filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteoinduction. It is a Class III device, reviewed by the Orthopedic panel.
What device class is NEK?
Class III. Typical premarket route: PMA.
Have NEK devices been recalled?
Yes: 8 product recalls across 2 recall events; the most recent began 2018-09-27.
Next steps
- Run an FDA pathway report with predicate devices for product code NEK
- Run a recall and safety report across every NEK manufacturer
- Watch product code NEK 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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