FDA 510(k)

Fitmore® 髋關節柄

K 號：K170072 · 2017-02-07

決定日期2017-02-07

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 2017-02-07 under 510(k) number K170072. 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 2017-02-07. The listed applicant is Zimmer GmbH. The 510(k) number is K170072.

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

Fitmore® Hip Stem received FDA 510(k) clearance on 2017-02-07, under 510(k) number K170072.

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

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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

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