FDA 510(k)

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote

K-Number: K200504 · 2020-07-29

ApplicantMed-El Elektromedizinische Geraete GmbH

Decision Date2020-07-29

Product CodePFO

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is a medical device manufactured by Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2020-07-29 under approval number K200504. 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 System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is a medical device that received FDA 510(k) clearance on 2020-07-29. It is manufactured by Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K200504.

When was BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote approved by the FDA?

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote received FDA 510(k) clearance on 2020-07-29, under approval number K200504.

What company makes BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is manufactured by Med-El Elektromedizinische Geraete GmbH.

What is the FDA product code for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote?

The FDA product code for BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote is PFO.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

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) K183373Bonebridge K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)

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 K183373BonebridgeMed-El Elektromedizinische Geraete GmbH K201983BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm)Med-El Elektromedizinische Geraete GmbH

Official Source

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