FDA 510(k)

DePuy Synthes多孔聚乙烯植入物和钛絲組合 – MR條件性

K 號：K183472 · 2019-03-13

決定日期2019-03-13

產品代碼FTM

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2019-03-13 under 510(k) number K183472. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is a medical device that received FDA 510(k) clearance on 2019-03-13. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K183472.

When did DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional receive FDA 510(k) clearance?

DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional received FDA 510(k) clearance on 2019-03-13, under 510(k) number K183472.

Who is the listed applicant for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

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

What is the FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional?

The FDA product code for DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional is FTM.

其他以 Synthes (USA) Products, LLC 為申請人之記錄

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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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