FDA 510(k)

臀部間隔模具；膝蓋間隔模具；肩膀間隔模具

K 號：K240856 · 2024-11-20

決定日期2024-11-20

產品代碼MBB

諮詢委員會或

決定相當於

器材摘要

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is the device name listed in this FDA 510(k) record. The listed applicant is Osartis GmbH. It received FDA 510(k) clearance on 2024-11-20 under 510(k) number K240856. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is a medical device that received FDA 510(k) clearance on 2024-11-20. The listed applicant is Osartis GmbH. The 510(k) number is K240856.

When did Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds receive FDA 510(k) clearance?

Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds received FDA 510(k) clearance on 2024-11-20, under 510(k) number K240856.

Who is the listed applicant for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

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

What is the FDA product code for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds?

The FDA product code for Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer Molds is MBB.

其他以 Osartis GmbH 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：MBB）

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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