FDA 510(k)

INFILOOP® 固定環 UHMWPE 緝合釘鈦金屬按鈕

K 號：K232886 · 2023-11-08

決定日期2023-11-08

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

INFILOOP® Fixed Loop UHMWPE Suture Titanium 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 2023-11-08 under 510(k) number K232886. 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 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is a medical device that received FDA 510(k) clearance on 2023-11-08. The listed applicant is Healthium Medtech Limited. The 510(k) number is K232886.

When did INFILOOP® Fixed Loop UHMWPE Suture Titanium Button receive FDA 510(k) clearance?

INFILOOP® Fixed Loop UHMWPE Suture Titanium Button received FDA 510(k) clearance on 2023-11-08, under 510(k) number K232886.

Who is the listed applicant for INFILOOP® Fixed Loop UHMWPE Suture Titanium 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 INFILOOP® Fixed Loop UHMWPE Suture Titanium Button?

The FDA product code for INFILOOP® Fixed Loop UHMWPE Suture Titanium Button is MBI.

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。

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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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官方來源

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