FDA 510(k)

Aequalis 升降柔軟肩關節系統

K 號：K190521 · 2019-06-12

決定日期2019-06-12

產品代碼KWS

諮詢委員會或

決定相當於

器材摘要

Aequalis Ascend Flex Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier S.A.S.. It received FDA 510(k) clearance on 2019-06-12 under 510(k) number K190521. 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 Aequalis Ascend Flex Shoulder System?

Aequalis Ascend Flex Shoulder System is a medical device that received FDA 510(k) clearance on 2019-06-12. The listed applicant is Tornier S.A.S.. The 510(k) number is K190521.

When did Aequalis Ascend Flex Shoulder System receive FDA 510(k) clearance?

Aequalis Ascend Flex Shoulder System received FDA 510(k) clearance on 2019-06-12, under 510(k) number K190521.

Who is the listed applicant for Aequalis Ascend Flex Shoulder System?

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

What is the FDA product code for Aequalis Ascend Flex Shoulder System?

The FDA product code for Aequalis Ascend Flex Shoulder System is KWS.

其他以 Tornier S.A.S. 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。

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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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