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FDA 510(k)

維特克斯無節點釘

K 號:K152262 · 2016-03-08

決定日期2016-03-08
產品代碼MBI
諮詢委員會或
決定相當於

器材摘要

Ventix Knotless Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2016-03-08 under 510(k) number K152262. 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 Ventix Knotless Anchors?

Ventix Knotless Anchors is a medical device that received FDA 510(k) clearance on 2016-03-08. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K152262.

When did Ventix Knotless Anchors receive FDA 510(k) clearance?

Ventix Knotless Anchors received FDA 510(k) clearance on 2016-03-08, under 510(k) number K152262.

Who is the listed applicant for Ventix Knotless Anchors?

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

What is the FDA product code for Ventix Knotless Anchors?

The FDA product code for Ventix Knotless Anchors is MBI.

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其他以 Biomet Manufacturing Corp 為申請人之記錄

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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。

官方來源

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