FDA 510(k)

美敦力全髋關節置换系統

K 號：K183129 · 2019-07-26

決定日期2019-07-26

產品代碼LPH

諮詢委員會或

決定相當於

器材摘要

Medtronic Total Hip Arthroplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Advanced Energy. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K183129. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Medtronic Total Hip Arthroplasty System?

Medtronic Total Hip Arthroplasty System is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is Medtronic Advanced Energy. The 510(k) number is K183129.

When did Medtronic Total Hip Arthroplasty System receive FDA 510(k) clearance?

Medtronic Total Hip Arthroplasty System received FDA 510(k) clearance on 2019-07-26, under 510(k) number K183129.

Who is the listed applicant for Medtronic Total Hip Arthroplasty System?

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

What is the FDA product code for Medtronic Total Hip Arthroplasty System?

The FDA product code for Medtronic Total Hip Arthroplasty System is LPH.

其他以 Medtronic Advanced Energy 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。

K181257PlasmaBlade X 3.0S，PlasmaBlade X 4.0 K170381侵入式封合器（MIS）Flex，侵入式封合器（MIS）Flex Mini K170610血液刀 K170296CoreCath 2.7S K152703PlasmaBlade TnA 鼻咽扁桃腺及腺體切除設備

相關器械（代碼：LPH）

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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