FDA 510(k)

應用式關節鏡縫釘系統

K 號：K180951 · 2019-01-03

決定日期2019-01-03

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Responsive Arthroscopy Suture Anchor System is the device name listed in this FDA 510(k) record. The listed applicant is Responsive Arthroscopy, LLC. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K180951. 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 Responsive Arthroscopy Suture Anchor System?

Responsive Arthroscopy Suture Anchor System is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Responsive Arthroscopy, LLC. The 510(k) number is K180951.

When did Responsive Arthroscopy Suture Anchor System receive FDA 510(k) clearance?

Responsive Arthroscopy Suture Anchor System received FDA 510(k) clearance on 2019-01-03, under 510(k) number K180951.

Who is the listed applicant for Responsive Arthroscopy Suture Anchor System?

The FDA 510(k) record lists Responsive Arthroscopy, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Responsive Arthroscopy Suture Anchor System?

The FDA product code for Responsive Arthroscopy Suture Anchor System is MBI.

其他以 Responsive Arthroscopy, LLC 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。

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