FDA 510(k)

ELEOS肢體保存系統配備BIOGRIP

K 號：K203090 · 2020-12-11

決定日期2020-12-11

產品代碼JDI

諮詢委員會或

決定相當於

器材摘要

ELEOS Limb Salvage System featuring BIOGRIP is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical. It received FDA 510(k) clearance on 2020-12-11 under 510(k) number K203090. 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 featuring BIOGRIP?

ELEOS Limb Salvage System featuring BIOGRIP is a medical device that received FDA 510(k) clearance on 2020-12-11. The listed applicant is Onkos Surgical. The 510(k) number is K203090.

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

ELEOS Limb Salvage System featuring BIOGRIP received FDA 510(k) clearance on 2020-12-11, under 510(k) number K203090.

Who is the listed applicant for ELEOS Limb Salvage System featuring BIOGRIP?

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 featuring BIOGRIP?

The FDA product code for ELEOS Limb Salvage System featuring BIOGRIP 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 K203588ELEOS™肢體保存系統

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。

K253515Zimmer Biomet OSS™ 骨科救傷系統 OsseoTi® 穿孔套管及增強件Biomet Orthopedics, Inc.K253434OSSTM 骨科救護系統Biomet, Inc.K252824Evolve AP杯，世界鳍杯，世界G-Zero Liner及奇數球頭Signature Orthopaedics Pty, Ltd.K243571trabecular金屬骨盆修復系統，骨盆內襯及限制性內襯Zimmer Biomet K240783Anthology 髋部釘；CPCS 髋部釘；股骨頭；R3 骨盆蓋內衬；Spectron 髋部釘；Synergy 髋部釘Smith & Nephew, Inc.K241716全球模組化更換系統，模組化更換系統，模組化旋轉軸承膝關節元件Howmedica Osteonics Corp., Dba Stryker Orthopaedics

官方來源

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