FDA 510(k)

DIP關節融合系統

K 號：K173616 · 2018-01-19

決定日期2018-01-19

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

DIP Arthrodesis System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K173616. 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 DIP Arthrodesis System?

DIP Arthrodesis System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is In2bones Sas. The 510(k) number is K173616.

When did DIP Arthrodesis System receive FDA 510(k) clearance?

DIP Arthrodesis System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K173616.

Who is the listed applicant for DIP Arthrodesis System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIP Arthrodesis System?

The FDA product code for DIP Arthrodesis System is HTY.

其他以 In2bones Sas 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。

K231699QUANTUM® 病患特定儀器設備（PSI）系統 K230313量子病人特定儀器設備（PSI）系統 K211883QUANTUM® 病患特定儀器設備（PSI）系統 K191380量子® 全踝人工關節 K173811TRIWAY 膝踝跟骨融合系統 (TTC)K170688PIT’Stop® 假植

查看所有 14 項裝置 →

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。