FDA 510(k)

Exeter V40 髋關節柄，Exeter X3 RimFit 杯

K 號：K193429 · 2020-08-13

決定日期2020-08-13

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2020-08-13 under 510(k) number K193429. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is a medical device that received FDA 510(k) clearance on 2020-08-13. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K193429.

When did Exeter V40 Femoral Stem, Exeter X3 RimFit Cup receive FDA 510(k) clearance?

Exeter V40 Femoral Stem, Exeter X3 RimFit Cup received FDA 510(k) clearance on 2020-08-13, under 510(k) number K193429.

Who is the listed applicant for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

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

What is the FDA product code for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup?

The FDA product code for Exeter V40 Femoral Stem, Exeter X3 RimFit Cup is JDI.

其他以 Howmedica Osteonics Corp. 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。

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相關器械（代碼：JDI）

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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