FDA 510(k)

KATOR 縫合錨釘

K 號：K173269 · 2018-05-30

決定日期2018-05-30

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

KATOR Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Kator, LLC. It received FDA 510(k) clearance on 2018-05-30 under 510(k) number K173269. 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 KATOR Suture Anchor?

KATOR Suture Anchor is a medical device that received FDA 510(k) clearance on 2018-05-30. The listed applicant is Kator, LLC. The 510(k) number is K173269.

When did KATOR Suture Anchor receive FDA 510(k) clearance?

KATOR Suture Anchor received FDA 510(k) clearance on 2018-05-30, under 510(k) number K173269.

Who is the listed applicant for KATOR Suture Anchor?

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

What is the FDA product code for KATOR Suture Anchor?

The FDA product code for KATOR Suture Anchor is MBI.

其他以 Kator, 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。

K162386KATOR 縫合錨釘

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。

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