FDA 510(k)

Tigon醫療按鈕系統

K 號：K211049 · 2021-08-04

決定日期2021-08-04

產品代碼MBI

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決定相當於

器材摘要

Tigon Medical Button System is the device name listed in this FDA 510(k) record. The listed applicant is Tigon Medical. It received FDA 510(k) clearance on 2021-08-04 under 510(k) number K211049. 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 Tigon Medical Button System?

Tigon Medical Button System is a medical device that received FDA 510(k) clearance on 2021-08-04. The listed applicant is Tigon Medical. The 510(k) number is K211049.

When did Tigon Medical Button System receive FDA 510(k) clearance?

Tigon Medical Button System received FDA 510(k) clearance on 2021-08-04, under 510(k) number K211049.

Who is the listed applicant for Tigon Medical Button System?

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

What is the FDA product code for Tigon Medical Button System?

The FDA product code for Tigon Medical Button System is MBI.

其他以 Tigon Medical 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。

K260921Tigon醫療靜態飛鏢全縫線固定針及飛鏢全縫線固定針系列 K252596Tigon醫療無節結合雙針槍全縫線釘 K242529Tigon醫療全縫針固著器（ASA）K240175Tigon醫療骨折、不穩定與重建（FIRE）K220464Tigon醫療Gryphon錨線 K182507提格恩醫療組織固定釘

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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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

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