FDA 510(k)

TRIGEN MAX 髌骨釘系統；INTERTAN MAX 髋骨骨折釘系統

K 號：K240061 · 2024-09-20

決定日期2024-09-20

產品代碼JDS

諮詢委員會或

決定相當於

器材摘要

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System 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 2024-09-20 under 510(k) number K240061. The device is classified under product code JDS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is a medical device that received FDA 510(k) clearance on 2024-09-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K240061.

When did TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System receive FDA 510(k) clearance?

TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System received FDA 510(k) clearance on 2024-09-20, under 510(k) number K240061.

Who is the listed applicant for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

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 TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System?

The FDA product code for TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System is JDS.

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 K252129AETOS肩關節系統無柄肱骨假體 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）

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相關器械（代碼：JDS）

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。

K243608TRIGEN 稳定螺母與清洗片Smith & Nephew, Inc.K241804TRIGEN INTERTAN 10S 钉系統Smith & Nephew, Inc.K233150NET品牌骨固定釘釋系統Narang Medical , Ltd.K230761TRIGEN 元 nail 钉系統Smith & Nephew, Inc.K201336DePuy Synthes 髌骨釘先進型，DePuy Synthes 骨髓釘固定螺釘，4.0 及 5.0mmSynthes (USA) Products, LLC K192003Auxein 钉固定系統Auxein Medical Private Limited

官方來源

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