FDA 510(k)

Fitmore 髋關節植入體

K 號：K192236 · 2019-11-05

決定日期2019-11-05

產品代碼KWY

諮詢委員會或

決定相當於

器材摘要

Fitmore Hip Stem is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer GmbH. It received FDA 510(k) clearance on 2019-11-05 under 510(k) number K192236. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Fitmore Hip Stem?

Fitmore Hip Stem is a medical device that received FDA 510(k) clearance on 2019-11-05. The listed applicant is Zimmer GmbH. The 510(k) number is K192236.

When did Fitmore Hip Stem receive FDA 510(k) clearance?

Fitmore Hip Stem received FDA 510(k) clearance on 2019-11-05, under 510(k) number K192236.

Who is the listed applicant for Fitmore Hip Stem?

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

What is the FDA product code for Fitmore Hip Stem?

The FDA product code for Fitmore Hip Stem is KWY.

其他以 Zimmer GmbH 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。

K211047CoCr 頭部 K200814Affixus(R) 自然釘(R) 系統上臂釘 K200112齊默髋關節置換設備 K193099解剖肩部系統 K193050Alloclassic Zweymuller SL股骨柄，Alloclassic Zweymuller SL偏心股骨柄 K193030Avenir Muller 植入物，Avenir 粘合固定髋關節植入物

查看所有 19 項裝置 →

相關器械（代碼：KWY）

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。

K253357b-ONE®雙極頭B-One Ortho, Corp.K243634Maxx Libertas雙極股頭 (雙極股)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UC K223441SpaceFlex 髋臼杯G21, S.R.L.K221794Vario-Cup 系統Waldemar Link GmbH & Co. KG K220492COPAL交換G 髋間隔離器Heraeus Medical GmbH

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。