FDA 510(k)

STROPP（足底板單隧道修復）

K 號：K160118 · 2016-05-03

決定日期2016-05-03

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

STROPP (Single Tunnel Repair of Plantar Plate) is the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2016-05-03 under 510(k) number K160118. 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 STROPP (Single Tunnel Repair of Plantar Plate)?

STROPP (Single Tunnel Repair of Plantar Plate) is a medical device that received FDA 510(k) clearance on 2016-05-03. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K160118.

When did STROPP (Single Tunnel Repair of Plantar Plate) receive FDA 510(k) clearance?

STROPP (Single Tunnel Repair of Plantar Plate) received FDA 510(k) clearance on 2016-05-03, under 510(k) number K160118.

Who is the listed applicant for STROPP (Single Tunnel Repair of Plantar Plate)?

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

What is the FDA product code for STROPP (Single Tunnel Repair of Plantar Plate)?

The FDA product code for STROPP (Single Tunnel Repair of Plantar Plate) is MBI.

其他以 Crossroads Extremity Systems, 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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