FDA 510(k)

德普伊森斯骨板及螺釘產品系列

K 號：K190750 · 2019-06-21

決定日期2019-06-21

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

DePuy Synthes Plates and Screws Portfolio is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K190750. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes Plates and Screws Portfolio?

DePuy Synthes Plates and Screws Portfolio is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is DePuy Synthes. The 510(k) number is K190750.

When did DePuy Synthes Plates and Screws Portfolio receive FDA 510(k) clearance?

DePuy Synthes Plates and Screws Portfolio received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190750.

Who is the listed applicant for DePuy Synthes Plates and Screws Portfolio?

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 Plates and Screws Portfolio?

The FDA product code for DePuy Synthes Plates and Screws Portfolio is HRS.

其他以 DePuy Synthes 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。

K233696DePuy Synthes 後退式股骨釘先進系統 K233255CROSSNAV導航啟用儀器 K233256機器人整合儀器 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：HRS）

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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官方來源

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