FDA 510(k)

AETOS肩關節系統無柄肱骨假體

K 號：K252129 · 2025-10-03

決定日期2025-10-03

產品代碼PKC

諮詢委員會或

決定相當於

器材摘要

AETOS Shoulder System Stemless Humeral Prosthesis is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2025-10-03 under 510(k) number K252129. The device is classified under product code PKC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AETOS Shoulder System Stemless Humeral Prosthesis?

AETOS Shoulder System Stemless Humeral Prosthesis is a medical device that received FDA 510(k) clearance on 2025-10-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K252129.

When did AETOS Shoulder System Stemless Humeral Prosthesis receive FDA 510(k) clearance?

AETOS Shoulder System Stemless Humeral Prosthesis received FDA 510(k) clearance on 2025-10-03, under 510(k) number K252129.

Who is the listed applicant for AETOS Shoulder System Stemless Humeral Prosthesis?

FDA 510(k) 記錄將史密斯與內夫公司（Smith & Nephew, Inc.）列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis?

The FDA product code for AETOS Shoulder System Stemless Humeral Prosthesis is PKC.

其他以 Smith & Nephew, 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。

K261462LANDMARK 全膝系統 K261968Q-FIX KNOTLESS 全縫線锚，2.8mm，附一條黑色無節縫線及一條藍色 MINITAPE 縫線（72205981）；Q-FIX KNOTLESS 全縫線锚，2.8mm，附一條藍色無節縫線及一條黑色 MINITAPE 縫線（72205982）K254084AETOS肩關節系統 - CONCELOC關節盤 K252416AETOS肩關節系統 Meta 肱骨假體尺寸 0 K251627BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（雜綉藍）；BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（雜綉黑）；BIORAPTOR 2.3 PK 緝合釘配ULTRABRAID (#2) 緝合線（白色）；BIORAPTOR CURVED 2.3 PK 緝合釘配ONE 38 ULTRABRAID (#2) 緝合線（雜綉黑）；BIORAPTOR CURVED 2.3 PK 緝合釘配ONE 38 ULTRABRAID (#2) 緝合線（雜綉藍）K243608TRIGEN 稳定螺母與清洗片

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相關器械（代碼：PKC）

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。

K262955OsseoFit無柄肩部系統Zimmer, Inc.K254154FX V135 EASYTECH® 肩關節系統FX Shoulder Solutions, Inc.K243248INHANCE INTACT™Depuy Ireland UC K241873OsseoFit無柄肩部系統Zimmer, Inc.K240716AETOS肩關節系統無柄肱骨假體Smith & Nephew, Inc.K221758SMR無柄解剖型Lima Corporate S.P.A.

官方來源

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