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FDA 510(k)

MTF 預縫合腱

K 號：K181633 · 2019-03-15

申請人Musculoskeletal Transplant Foundation
決定日期2019-03-15
產品代碼GAT
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

MTF Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Musculoskeletal Transplant Foundation. It received FDA 510(k) clearance on 2019-03-15 under 510(k) number K181633. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MTF Pre-Sutured Tendon?

MTF Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2019-03-15. The listed applicant is Musculoskeletal Transplant Foundation. The 510(k) number is K181633.

When did MTF Pre-Sutured Tendon receive FDA 510(k) clearance?

MTF Pre-Sutured Tendon received FDA 510(k) clearance on 2019-03-15, under 510(k) number K181633.

Who is the listed applicant for MTF Pre-Sutured Tendon?

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

What is the FDA product code for MTF Pre-Sutured Tendon?

The FDA product code for MTF Pre-Sutured Tendon is GAT.

相關臨床試驗

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相關器械（代碼：GAT）

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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