FDA 510(k)

鍵節固定系統（HTS）

K 號：K190926 · 2019-07-23

決定日期2019-07-23

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

Hammertoe Truss System (HTS) is the device name listed in this FDA 510(k) record. The listed applicant is 4Web, Inc.. It received FDA 510(k) clearance on 2019-07-23 under 510(k) number K190926. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hammertoe Truss System (HTS)?

Hammertoe Truss System (HTS) is a medical device that received FDA 510(k) clearance on 2019-07-23. The listed applicant is 4Web, Inc.. The 510(k) number is K190926.

When did Hammertoe Truss System (HTS) receive FDA 510(k) clearance?

Hammertoe Truss System (HTS) received FDA 510(k) clearance on 2019-07-23, under 510(k) number K190926.

Who is the listed applicant for Hammertoe Truss System (HTS)?

The FDA 510(k) record lists 4Web, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hammertoe Truss System (HTS)?

The FDA product code for Hammertoe Truss System (HTS) is HTY.

其他以 4Web, Inc. 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：HTY）

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。

K262722原始K釘（P99-193-1410）Paragon 28, Inc.K253325ZipToe™ 間趾融合系統Toetal Solutions K252657影響 PEEK 聯合釘系統Nvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ 強韌指甲系統OrthoPediatrics Corp.K250646影響 PEEK 聯合釘系統Nvision Biomedical Technologies

官方來源

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