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FDA 510(k)

Bonebridge

K-Number: K183373 · 2019-03-07

ApplicantMed-El Elektromedizinische Geraete GmbH
Decision Date2019-03-07
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Bonebridge is a medical device manufactured by Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2019-03-07 under approval number K183373. The device is classified under product code PFO. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bonebridge?

Bonebridge is a medical device that received FDA 510(k) clearance on 2019-03-07. It is manufactured by Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K183373.

When was Bonebridge approved by the FDA?

Bonebridge received FDA 510(k) clearance on 2019-03-07, under approval number K183373.

What company makes Bonebridge?

Bonebridge is manufactured by Med-El Elektromedizinische Geraete GmbH.

What is the FDA product code for Bonebridge?

The FDA product code for Bonebridge is PFO.

Other Devices by Med-El Elektromedizinische Geraete GmbH

DEN170009Bonebridge K172460ADHEAR System K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

Related Devices (Code: PFO)

DEN170009BonebridgeMed-El Elektromedizinische Geraete GmbH K191921Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical InstrumentsCochlear Americas K191457BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm)Med-El Elektromedizinische Geraete GmbH K190589Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical InstrumentsCochlear Americas K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH K200504BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 RemoteMed-El Elektromedizinische Geraete GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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