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FDA 510(k)

Tornier肩胛骨重建系統（Tornier HRS）；Tornier Perform肩胛骨系統 - 植骨（Tornier PHS-Stem）

K 號：K241878 · 2024-12-06

申請人Stryker Corporation (Tornier, Inc.)
決定日期2024-12-06
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); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) 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 2024-12-06 under 510(k) number K241878. 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 Perform Humeral System - Stem (Tornier PHS-Stem)?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Stryker Corporation (Tornier, Inc.). The 510(k) number is K241878.

When did Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) receive FDA 510(k) clearance?

Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K241878.

Who is the listed applicant for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

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); Tornier Perform Humeral System - Stem (Tornier PHS-Stem)?

The FDA product code for Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) is KWS.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K241609Tornier 肱骨重建系統 (Tornier HRS)

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.K241609Tornier 肱骨重建系統 (Tornier HRS)Stryker Corporation (Tornier, Inc.)

官方來源

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