FDA 510(k)

Aequalis PerFORM+ 肩關節系統

K 號：K160975 · 2016-06-10

決定日期2016-06-10

產品代碼KWS

諮詢委員會或

決定相當於

器材摘要

Aequalis PerFORM+ Shoulder System is the device name listed in this FDA 510(k) record. The listed applicant is Tornier, Inc.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K160975. 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 PerFORM+ Shoulder System?

Aequalis PerFORM+ Shoulder System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Tornier, Inc.. The 510(k) number is K160975.

When did Aequalis PerFORM+ Shoulder System receive FDA 510(k) clearance?

Aequalis PerFORM+ Shoulder System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160975.

Who is the listed applicant for Aequalis PerFORM+ Shoulder System?

FDA 510(k) 記錄將 Tornier, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Aequalis PerFORM+ Shoulder System?

The FDA product code for Aequalis PerFORM+ Shoulder System is KWS.

其他以 Tornier, Inc. 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。

K260721Tornier Perform 高級肩胛盂 K252788Tornier Perform™ 反向單柱盂蓋 (Perform Mono)K251686Tornier 臂骨重建系統 Max (Tornier HRS Max)K230352Tornier肩胛骨釘與Tornier長肩胛骨釘 K220914Tornier Perform 臂骨系統 – 骨折 K220418Tornier Perform 臂骨系統 – 齒冠式

查看所有 19 項裝置 →

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。