FDA 510(k)

ELEOS肢體保存系統

K 號：K211677 · 2021-07-28

決定日期2021-07-28

產品代碼KRO

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 2021-07-28 under 510(k) number K211677. The device is classified under product code KRO. 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 2021-07-28. The listed applicant is Onkos Surgical. The 510(k) number is K211677.

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

ELEOS Limb Salvage System received FDA 510(k) clearance on 2021-07-28, under 510(k) number K211677.

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 KRO.

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 K203815ELEOS肢體保存系統搭配BioGrip K203588ELEOS™肢體保存系統 K203090ELEOS肢體保存系統配備BIOGRIP

相關器械（代碼：KRO）

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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