FDA 510(k)

LigaMetrics 緝合釘

K 號：K171964 · 2017-09-19

決定日期2017-09-19

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

LigaMetrics Suture Anchors is the device name listed in this FDA 510(k) record. The listed applicant is Mortise Medical, LLC. It received FDA 510(k) clearance on 2017-09-19 under 510(k) number K171964. 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 LigaMetrics Suture Anchors?

LigaMetrics Suture Anchors is a medical device that received FDA 510(k) clearance on 2017-09-19. The listed applicant is Mortise Medical, LLC. The 510(k) number is K171964.

When did LigaMetrics Suture Anchors receive FDA 510(k) clearance?

LigaMetrics Suture Anchors received FDA 510(k) clearance on 2017-09-19, under 510(k) number K171964.

Who is the listed applicant for LigaMetrics Suture Anchors?

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

What is the FDA product code for LigaMetrics Suture Anchors?

The FDA product code for LigaMetrics Suture Anchors is MBI.

其他以 Mortise Medical, LLC 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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