PONTO BONE ANCHORED HEARING SYSTEM— 510(k) K121228

Name: FDA 510(k) clearance K121228
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Substantially Equivalent

Oticon Medical AB

FDA 510(k) clearance K121228 for PONTO BONE ANCHORED HEARING SYSTEM, Substantially Equivalent on 2012-09-07. Applicant: Oticon Medical AB. Device class: 2.

Clearance details

Applicant: Oticon Medical AB
Product code: Code MAH
Device class: Class 2
Regulation: 21 CFR 874.3302
Advisory panel: Ear, Nose, Throat
Date received: 2012-04-23
Decision date: 2012-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Askim, SE

Download summary PDF View on FDA.gov ↗

Recent devices under product code MAH

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K261142 — Ponto 5 Mini; Ponto 5 Superpower2026-08-26
K203807 — Ponto Bone Anchored Hearing System, MONO Surgery Kit2021-03-03
K182116 — BA310 Abutment, BIA310 Implant/Abutment2018-12-19
K152820 — Ponto Bone Anchored Hearing System2016-01-22
K152067 — Ponto bone anchored hearing system2015-11-23

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K240614 — Sentio Ti Implant Kit; Sentio 1 Mini; Genie Medical BAHS2024-07-10
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K190540 — Ponto 42019-05-02
K161671 — Ponto 3, Ponto 3 Power and Ponto 3 SuperPower2016-09-29

Adverse events under product code MAH

product code MAH

Injury: 4,155
Total: 4,155

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.