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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 a medical device manufactured by Oticon Medical AB. It received FDA 510(k) clearance on 2021-03-03 under approval 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. It is manufactured by Oticon Medical AB. The 510(k) number is K203807.

When was Ponto Bone Anchored Hearing System, MONO Surgery Kit approved by the FDA?

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

What company makes Ponto Bone Anchored Hearing System, MONO Surgery Kit?

Ponto Bone Anchored Hearing System, MONO Surgery Kit is manufactured by Oticon Medical AB.

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.

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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: 40866856 Prognostic value of nutritional risk assessment indices in patients with digestive system tumors. BMC cancer (2025) PMID: 40624055 Establishment of a clinical workflow for in vivo Raman spectroscopy during head and neck cancer surgery. Scientific reports (2025)

Other Devices by Oticon Medical AB

K161671Ponto 3, Ponto 3 Power and Ponto 3 SuperPower K152820Ponto Bone Anchored Hearing System K190540Ponto 4 K213733Ponto 5 SuperPower K211640Ponto 5 Mini K240614Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS

View all 7 devices →

Related Devices (Code: MAH)

K152820Ponto Bone Anchored Hearing SystemOticon Medical AB K182116BA310 Abutment, BIA310 Implant/AbutmentCochlear Americas

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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