FDA 510(k)

觸媒 CSR 压縮式上臂元件

K 號：K182500 · 2019-01-11

決定日期2019-01-11

產品代碼KWT

諮詢委員會或

決定相當於

器材摘要

Catalyst CSR Press-Fit Humeral Components is the device name listed in this FDA 510(k) record. The listed applicant is Catalyst Orthoscience, Inc.. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K182500. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Catalyst CSR Press-Fit Humeral Components?

Catalyst CSR Press-Fit Humeral Components is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K182500.

When did Catalyst CSR Press-Fit Humeral Components receive FDA 510(k) clearance?

Catalyst CSR Press-Fit Humeral Components received FDA 510(k) clearance on 2019-01-11, under 510(k) number K182500.

Who is the listed applicant for Catalyst CSR Press-Fit Humeral Components?

The FDA 510(k) record lists Catalyst Orthoscience, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalyst CSR Press-Fit Humeral Components?

The FDA product code for Catalyst CSR Press-Fit Humeral Components is KWT.

其他以 Catalyst Orthoscience, Inc. 為申請人之記錄

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K252418催化劑F1x肩部系統 K234105催化劑F1x肩部系統 K232583Catalyst R1 頸部外翻系統 K223655Catalyst R1 頸部外翻系統 K222317催化 EA 可轉接式肩部針 K213349Catalyst R1 頸部外翻系統

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相關器械（代碼：KWT）

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。

K262173N22 選擇性肱骨頭Shoulder Innovations, Inc.K250713Equinoxe® 肱骨重建義肢；Equinoxe® 無柄肩關節植入體Exactech, Inc.K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO肩部置換系統Implantcast GmbH K241817InSet 全肩關節系統Shoulder Innovations, Inc.K231657AGILON® XO肩部置換系統Implantcast GmbH

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