FDA 510(k)

ACHIEVE 部分關節系統

K 號：K242307 · 2024-12-16

決定日期2024-12-16

產品代碼NJD

諮詢委員會或

決定相當於

器材摘要

ACHIEVE Partial Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Ignite Orthomotion. It received FDA 510(k) clearance on 2024-12-16 under 510(k) number K242307. The device is classified under product code NJD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ACHIEVE Partial Knee System?

ACHIEVE Partial Knee System is a medical device that received FDA 510(k) clearance on 2024-12-16. The listed applicant is Ignite Orthomotion. The 510(k) number is K242307.

When did ACHIEVE Partial Knee System receive FDA 510(k) clearance?

ACHIEVE Partial Knee System received FDA 510(k) clearance on 2024-12-16, under 510(k) number K242307.

Who is the listed applicant for ACHIEVE Partial Knee System?

The FDA 510(k) record lists Ignite Orthomotion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACHIEVE Partial Knee System?

The FDA product code for ACHIEVE Partial Knee System is NJD.

其他以 Ignite Orthomotion 為申請人之記錄

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。

K251975Achieve 部分膝關節系統 - 多孔涂層 CoCrMo 髋骨-component

相關器械（代碼：NJD）

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。

K251975Achieve 部分膝關節系統 - 多孔涂層 CoCrMo 髋骨-componentIgnite Orthomotion K222653JOURNEY II UK™ 及 ENGAGE™ 非骨水泥部分膝關節系統Smith+Nephew, Inc.K190439Engage™ 部分膝關節系統Engage Uni, LLC

官方來源

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