De Novo
DEN160062: IlluminOss Bone Stabilization System
FDA De Novo · illminoss medical, inc. · decided Dec 19, 2017
Key facts
| De Novo number | DEN160062 |
|---|---|
| Device name | IlluminOss Bone Stabilization System |
| Applicant | illminoss medical, inc. |
| Product code | QAD |
| Date received | Dec 28, 2016 |
| Decision date | Dec 19, 2017 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Orthopedic |
| FEI number | 3006845464 |
At a glance
- None Later 510(k)s citing this De Novo
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None Recall events
- No Decision summary on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About De Novo classification requests
The De Novo pathway classifies novel low- to moderate-risk devices that have no legally marketed predicate; each granted request creates a new classification regulation and product code.
Source: U.S. Food and Drug Administration (FDA), De Novo database · Source date: