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FDA 510(k)

T-Button® 調節式環形 UHMWPE 緝線 PEEK 按鈕，關閉按鈕，T-Button® S 調節式環形 UHMWPE 緝線 PEEK 按鈕，開啟按鈕

K 號：K231404 · 2023-08-04

申請人Healthium Medtech Limited
決定日期2023-08-04
產品代碼MBI
諮詢委員會或
決定相當於

器材摘要

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is the device name listed in this FDA 510(k) record. The listed applicant is Healthium Medtech Limited. It received FDA 510(k) clearance on 2023-08-04 under 510(k) number K231404. 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 T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is a medical device that received FDA 510(k) clearance on 2023-08-04. The listed applicant is Healthium Medtech Limited. The 510(k) number is K231404.

When did T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button receive FDA 510(k) clearance?

T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button received FDA 510(k) clearance on 2023-08-04, under 510(k) number K231404.

Who is the listed applicant for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

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

What is the FDA product code for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button?

The FDA product code for T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button is MBI.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Healthium Medtech Limited 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。

K231033CEPTRE® 結節型超高分子量聚乙烯縫線 PEEK 鈎釘K230891SURESTITCH™ UHMWPE 緝合釘 PEEK 植片 半月板修復植入體K232886INFILOOP® 固定環 UHMWPE 緝合釘 鈦金屬按鈕K223889Stativ® 結節超高分子量聚乙烯縫合釘

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, LLCK262677Iconix Knotless TRiverpoint MedicalK262047Grappler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

官方來源

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