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FDA 510(k)

Bonebridge

K-Number: K183373 · 2019-03-07

Decision Date2019-03-07
Product CodePFO
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Bonebridge is the device name listed in this FDA 510(k) record. The listed applicant is Med-El Elektromedizinische Geraete GmbH. It received FDA 510(k) clearance on 2019-03-07 under 510(k) 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. The listed applicant is Med-El Elektromedizinische Geraete GmbH. The 510(k) number is K183373.

When did Bonebridge receive FDA 510(k) clearance?

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

Who is the listed applicant for Bonebridge?

The FDA 510(k) record lists Med-El Elektromedizinische Geraete GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Bonebridge?

The FDA product code for Bonebridge is PFO.

Other records listing Med-El Elektromedizinische Geraete GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: PFO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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