The following data is part of a De Novo classification by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge.
| DeNovo ID | DEN170009 |
| Device Name: | Bonebridge |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | MED-EL Elektromedizinische Geraete GmbH fuerstenweg 77a Innsbruck, AT 6020 |
| Contact | Elizabeth Gfoeller |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Ear Nose & Throat |
| Classification Advisory | Ear Nose & Throat |
| Type | Direct |
| Date Received | 2017-02-13 |
| Decision Date | 2018-07-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09008738521805 | DEN170009 | 000 |
| 09008738512537 | DEN170009 | 000 |
| 09008738512544 | DEN170009 | 000 |
| 09008738512551 | DEN170009 | 000 |
| 09008738512568 | DEN170009 | 000 |
| 09008738515590 | DEN170009 | 000 |
| 09008738515606 | DEN170009 | 000 |
| 09008738517839 | DEN170009 | 000 |
| 09008738517846 | DEN170009 | 000 |
| 09008737527969 | DEN170009 | 000 |
| 09008738515293 | DEN170009 | 000 |
| 09008738510328 | DEN170009 | 000 |