FDA 510(k)

催化 EA 可轉接式肩部針

K 號：K222317 · 2022-11-10

決定日期2022-11-10

產品代碼KWS

諮詢委員會或

決定相當於

器材摘要

Catalyst EA Convertible Stemmed Shoulder 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 2022-11-10 under 510(k) number K222317. The device is classified under product code KWS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Catalyst EA Convertible Stemmed Shoulder?

Catalyst EA Convertible Stemmed Shoulder is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is Catalyst Orthoscience, Inc.. The 510(k) number is K222317.

When did Catalyst EA Convertible Stemmed Shoulder receive FDA 510(k) clearance?

Catalyst EA Convertible Stemmed Shoulder received FDA 510(k) clearance on 2022-11-10, under 510(k) number K222317.

Who is the listed applicant for Catalyst EA Convertible Stemmed Shoulder?

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 EA Convertible Stemmed Shoulder?

The FDA product code for Catalyst EA Convertible Stemmed Shoulder is KWS.

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 K213349Catalyst R1 頸部外翻系統 K211991Catalyst R1 頸部外翻系統

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相關器械（代碼：KWS）

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。

K260721Tornier Perform 高級肩胛盂Tornier, Inc.K254084AETOS肩關節系統 - CONCELOC關節盤Smith & Nephew, Inc.K252418催化劑F1x肩部系統Catalyst Orthoscience, Inc.K252416AETOS肩關節系統 Meta 肱骨假體尺寸 0Smith & Nephew, Inc.K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A.K241878Tornier肩胛骨重建系統（Tornier HRS）；Tornier Perform肩胛骨系統 - 植骨（Tornier PHS-Stem）Stryker Corporation (Tornier, Inc.)

官方來源

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