FDA 510(k)

NUVENTUS NV.C™ 假肢零件

K 號：K251220 · 2025-07-28

決定日期2025-07-28

產品代碼NHA

諮詢委員會DE

決定相當於

器材摘要

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

常見問題

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. The listed applicant is Infinitum Eta, Ltd.. The 510(k) number is K251220.

When did NUVENTUS NV.C™ Prosthetic Components receive FDA 510(k) clearance?

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

Who is the listed applicant for NUVENTUS NV.C™ Prosthetic Components?

The FDA 510(k) record lists Infinitum Eta, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

其他以 Infinitum Eta, Ltd. 為申請人之記錄

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K243317NUVENTUS NV.C™ 外科儀器盒及托盤 K233081NUVENTUS NV.C™ 齿植系統

相關器械（代碼：NHA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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