Bonebridge
FDA 510(k) clearance DEN170009 · decided 2018-07-20
Clearance details
- K-number
- DEN170009
- Device name
- Bonebridge
- Applicant
- Med-El Elektromedizinische Geraete GmbH
- Decision
- Unknown
- Date received
- 2017-02-13
- Decision date
- 2018-07-20
- Days to decision
- 522 days
- Clearance type
- Direct
- Product code
- PFO
- Device class
- 2
- Regulation number
- 874.3340
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Innsbruck, AT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.