FDA 510(k)

催化劑 CSR 3 鋸齒關節

K 號：K173812 · 2018-03-09

決定日期2018-03-09

產品代碼KWT

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決定相當於

器材摘要

Catalyst CSR 3 Peg Glenoids 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 2018-03-09 under 510(k) number K173812. 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 3 Peg Glenoids?

Catalyst CSR 3 Peg Glenoids is a medical device that received FDA 510(k) clearance on 2018-03-09. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K173812.

When did Catalyst CSR 3 Peg Glenoids receive FDA 510(k) clearance?

Catalyst CSR 3 Peg Glenoids received FDA 510(k) clearance on 2018-03-09, under 510(k) number K173812.

Who is the listed applicant for Catalyst CSR 3 Peg Glenoids?

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 3 Peg Glenoids?

The FDA product code for Catalyst CSR 3 Peg Glenoids is KWT.

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

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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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