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FDA 510(k)

NUVENTUS NV.C™ Prosthetic Components

K-Number: K251220 · 2025-07-28

ApplicantInfinitum Eta, Ltd.
Decision Date2025-07-28
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NUVENTUS NV.C™ Prosthetic Components is a medical device manufactured by Infinitum Eta, Ltd.. It received FDA 510(k) clearance on 2025-07-28 under approval number K251220. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUVENTUS NV.C™ Prosthetic Components?

NUVENTUS NV.C™ Prosthetic Components is a medical device that received FDA 510(k) clearance on 2025-07-28. It is manufactured by Infinitum Eta, Ltd.. The 510(k) number is K251220.

When was NUVENTUS NV.C™ Prosthetic Components approved by the FDA?

NUVENTUS NV.C™ Prosthetic Components received FDA 510(k) clearance on 2025-07-28, under approval number K251220.

What company makes NUVENTUS NV.C™ Prosthetic Components?

NUVENTUS NV.C™ Prosthetic Components is manufactured by Infinitum Eta, Ltd..

What is the FDA product code for NUVENTUS NV.C™ Prosthetic Components?

The FDA product code for NUVENTUS NV.C™ Prosthetic Components is NHA.

Related Clinical Trials

NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026)

Other Devices by Infinitum Eta, Ltd.

K233081NUVENTUS NV.C™ Dental Implant System K243317NUVENTUS NV.C™ Surgical Cassette and Tray

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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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