FDA 510(k)

Auxilock GFS Mini, GFS II 大型, 和 GFS Ultimate

K 號：K213018 · 2022-11-18

決定日期2022-11-18

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K213018. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K213018.

When did Auxilock GFS Mini, GFS II Large, and GFS Ultimate receive FDA 510(k) clearance?

Auxilock GFS Mini, GFS II Large, and GFS Ultimate received FDA 510(k) clearance on 2022-11-18, under 510(k) number K213018.

Who is the listed applicant for Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

The FDA 510(k) record lists Auxein Medical Private Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auxilock GFS Mini, GFS II Large, and GFS Ultimate?

The FDA product code for Auxilock GFS Mini, GFS II Large, and GFS Ultimate is MBI.

其他以 Auxein Medical Private Limited 為申請人之記錄

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K221787Auxein 的 DHS/DCS 板系統 K213059胫骨及排骨系統 K213110AUXILOCK PEEK OPTIMA 螺釘內縫合針，AUXILOCK ROTADOR PEEK OPTIMA 螺釘內縫合針 K213108肱骨與尺骨系統 K213014Varixis 肘關節系統 K213109Auxilock Draw Tight 緝線基礎固定針

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相關器械（代碼：MBI）

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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