FDA 510(k)

ICONN Square 2.5MM 緝合釘

K 號：K172491 · 2017-11-29

決定日期2017-11-29

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

ICONN Square 2.5MM Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Iconn Orthopedics, LLC. It received FDA 510(k) clearance on 2017-11-29 under 510(k) number K172491. 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 ICONN Square 2.5MM Suture Anchor?

ICONN Square 2.5MM Suture Anchor is a medical device that received FDA 510(k) clearance on 2017-11-29. The listed applicant is Iconn Orthopedics, LLC. The 510(k) number is K172491.

When did ICONN Square 2.5MM Suture Anchor receive FDA 510(k) clearance?

ICONN Square 2.5MM Suture Anchor received FDA 510(k) clearance on 2017-11-29, under 510(k) number K172491.

Who is the listed applicant for ICONN Square 2.5MM Suture Anchor?

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

What is the FDA product code for ICONN Square 2.5MM Suture Anchor?

The FDA product code for ICONN Square 2.5MM Suture Anchor is MBI.

其他以 Iconn Orthopedics, 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）

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