Bonebridge
Active Implantable Bone Conduction Hearing System
MED-EL Elektromedizinische Geraete GmbH
The following data is part of a premarket notification filed by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge.
Pre-market Notification Details
| Device ID | K183373 |
| 510k Number | K183373 |
| Device Name: | Bonebridge |
| Classification | Active Implantable Bone Conduction Hearing System |
| Applicant | MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Contact | Stephanie Haselwanter |
| Correspondent | Stephanie Haselwanter MED-EL Elektromedizinische Geraete GmbH Fuerstenweg 77a Innsbruck, AT 6020 |
| Product Code | PFO |
| CFR Regulation Number | 874.3340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-06 |
| Decision Date | 2019-03-07 |
| Summary: | summary |
Trademark Results [Bonebridge]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BONEBRIDGE 79084534 4181231 Live/Registered |
Med-El Elektromedizinische Geräte Gesellschaft m.b.H. 2010-05-03 |
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