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FDA 510(k)

Ponto Bone Anchored Hearing System, MONO Surgery Kit

K-Number: K203807 · 2021-03-03

ApplicantOticon Medical AB
Decision Date2021-03-03
Product CodeMAH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Ponto Bone Anchored Hearing System, MONO Surgery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Oticon Medical AB. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K203807. The device is classified under product code MAH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ponto Bone Anchored Hearing System, MONO Surgery Kit?

Ponto Bone Anchored Hearing System, MONO Surgery Kit is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Oticon Medical AB. The 510(k) number is K203807.

When did Ponto Bone Anchored Hearing System, MONO Surgery Kit receive FDA 510(k) clearance?

Ponto Bone Anchored Hearing System, MONO Surgery Kit received FDA 510(k) clearance on 2021-03-03, under 510(k) number K203807.

Who is the listed applicant for Ponto Bone Anchored Hearing System, MONO Surgery Kit?

The FDA 510(k) record lists Oticon Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ponto Bone Anchored Hearing System, MONO Surgery Kit?

The FDA product code for Ponto Bone Anchored Hearing System, MONO Surgery Kit is MAH.

Related Clinical Trials

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NCT06976086Pediatric Expansion Study of the Sentio SystemACTIVE_NOT_RECRUITING

Other records listing Oticon Medical AB 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.

K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHSK213733Ponto 5 SuperPowerK211640Ponto 5 MiniK190540Ponto 4K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPowerK152820Ponto Bone Anchored Hearing System

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Related Devices (Code: MAH)

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.

K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear AmericasK152820Ponto Bone Anchored Hearing SystemOticon Medical AB

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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