FDA 510(k)

ELEOS™肢體保存系統

K 號：K203588 · 2021-02-05

決定日期2021-02-05

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

ELEOS™ Limb Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2021-02-05 under 510(k) number K203588. 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 ELEOS™ Limb Salvage System?

ELEOS™ Limb Salvage System is a medical device that received FDA 510(k) clearance on 2021-02-05. The listed applicant is Onkos Surgical. The 510(k) number is K203588.

When did ELEOS™ Limb Salvage System receive FDA 510(k) clearance?

ELEOS™ Limb Salvage System received FDA 510(k) clearance on 2021-02-05, under 510(k) number K203588.

Who is the listed applicant for ELEOS™ Limb Salvage System?

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

What is the FDA product code for ELEOS™ Limb Salvage System?

The FDA product code for ELEOS™ Limb Salvage System is JDI.

其他以 Onkos Surgical 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。

K212815My3D® 个性化骨盆重建設備 K211677ELEOS肢體保存系統 K203815ELEOS肢體保存系統搭配BioGrip K203090ELEOS肢體保存系統配備BIOGRIP

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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