De Novo
DEN180012: LOADPRO™ Intraoperative Rod Strain Sensor
FDA De Novo · intellirod spine, inc. · decided Mar 28, 2019
Key facts
| De Novo number | DEN180012 |
|---|---|
| Device name | LOADPRO™ Intraoperative Rod Strain Sensor |
| Applicant | intellirod spine, inc. |
| Product code | QFP |
| Date received | Mar 14, 2018 |
| Decision date | Mar 28, 2019 |
| Decision | granted (DENG) |
| FDA classification | Class II |
| Review panel | Orthopedic |
At a glance
- None Later 510(k)s citing this De Novo
- None UDI device identifiers (GUDID)
- None 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: