FDA 510(k)

Tornier 肱骨重建系統 (Tornier HRS)

K 號：K241609 · 2024-09-10

決定日期2024-09-10

產品代碼KWS

諮詢委員會或

決定相當於

器材摘要

Tornier Humeral Reconstruction System (Tornier HRS) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation (Tornier, Inc.). It received FDA 510(k) clearance on 2024-09-10 under 510(k) number K241609. 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 Tornier Humeral Reconstruction System (Tornier HRS)?

Tornier Humeral Reconstruction System (Tornier HRS) is a medical device that received FDA 510(k) clearance on 2024-09-10. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241609.

When did Tornier Humeral Reconstruction System (Tornier HRS) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS) received FDA 510(k) clearance on 2024-09-10, under 510(k) number K241609.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS)?

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

What is the FDA product code for Tornier Humeral Reconstruction System (Tornier HRS)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS) is KWS.

其他以 Stryker Corporation (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。

K260102Tornier Perform Reversed Glenoid和Tornier Perform Reversed Augmented Glenoid Shoulder System的設備名稱 K241878Tornier肩胛骨重建系統（Tornier HRS）；Tornier Perform肩胛骨系統 - 植骨（Tornier PHS-Stem）

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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