NUVENTUS NV.C Prosthetic Components— 510(k) K251220

Name: FDA 510(k) clearance K251220
Creator: U.S. Food and Drug Administration
Published: 2025-07-28

Substantially Equivalent

Infinitum Eta, Ltd.

FDA 510(k) clearance K251220 for NUVENTUS NV.C Prosthetic Components, Substantially Equivalent on 2025-07-28. Applicant: Infinitum Eta, Ltd.. Device class: 2.

Clearance details

Applicant: Infinitum Eta, Ltd.
Product code: Code NHA
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2025-04-21
Decision date: 2025-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petach Tikva, IL

Download summary PDF View on FDA.gov ↗

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Adverse events under product code NHA

product code NHA

Injury: 1,270
Malfunction: 2,860
Total: 4,130

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.