FDA 510(k)

DePuy Synthes 髋關節頭系統

K 號：K172872 · 2018-03-05

決定日期2018-03-05

產品代碼KTT

諮詢委員會或

決定相當於

器材摘要

DePuy Synthes Femoral Neck System is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2018-03-05 under 510(k) number K172872. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes Femoral Neck System?

DePuy Synthes Femoral Neck System is a medical device that received FDA 510(k) clearance on 2018-03-05. The listed applicant is DePuy Synthes. The 510(k) number is K172872.

When did DePuy Synthes Femoral Neck System receive FDA 510(k) clearance?

DePuy Synthes Femoral Neck System received FDA 510(k) clearance on 2018-03-05, under 510(k) number K172872.

Who is the listed applicant for DePuy Synthes Femoral Neck System?

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

What is the FDA product code for DePuy Synthes Femoral Neck System?

The FDA product code for DePuy Synthes Femoral Neck System is KTT.

其他以 DePuy Synthes 為申請人之記錄

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K233696DePuy Synthes 後退式股骨釘先進系統 K233256機器人整合儀器 K233255CROSSNAV導航啟用儀器 K233254TELIKEN 系統導航準備儀器 K233665德普伊辛斯 VOLT Mini 適應性骨折板系統，德普伊辛斯 VOLT 小型骨折板系統 K231922德普伊合成 MAXFRAME 自動結構系統

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相關器械（代碼：KTT）

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。

K254087MAXFRAME AUTOSTRUT™ 內建藍牙多軸校正系統Synthes (USA) Products, LLC K260900DYNEX® 外固定系統Vilex, LLC K260112QuikFix 外固定器：膝蓋跨包Stabiliz Orthopaedics, Inc.K253291優越系統Blue Ocean Global K253613猴環外環固定系統Paragon 28, Inc.K253202霍夫曼LRF系統Stryker GmbH

官方來源

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