Bonebridge

Active Implantable Bone Conduction Hearing System

MED-EL Elektromedizinische Geraete GmbH

The following data is part of a De Novo classification by Med-el Elektromedizinische Geraete Gmbh with the FDA for Bonebridge.

Pre-market Notification Details

DeNovo IDDEN170009
Device Name:Bonebridge
ClassificationActive Implantable Bone Conduction Hearing System
Applicant MED-EL Elektromedizinische Geraete GmbH fuerstenweg 77a Innsbruck,  AT 6020
ContactElizabeth Gfoeller
Product CodePFO  
CFR Regulation Number874.3340 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice 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 BoardEar Nose & Throat
Classification AdvisoryEar Nose & Throat
TypeDirect
Date Received2017-02-13
Decision Date2018-07-20
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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

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