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FDA 510(k)

Q-FIX 無結節全縫線墊板，1.8 毫米，配有一根 ULTRABRAID 縫線，藍色；Q-FIX 無結節全縫線墊板，1.8 毫米，配有一根 ULTRABRAID 縫線，雙織藍色；Q-FIX 無結節全縫線墊板，1.8 毫米，配有一根 MINITAPE 縫線，藍色；Q-FIX 無結節全縫線墊板，1.8 毫米，配有一根 MINITAPE 縫線，雙織藍色

K 號：K241435 · 2024-06-20

申請人Smith & Nephew, Inc.
決定日期2024-06-20
產品代碼MBI
諮詢委員會或
決定相當於

器材摘要

Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue 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 2024-06-20 under 510(k) number K241435. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue?

Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue is a medical device that received FDA 510(k) clearance on 2024-06-20. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K241435.

When did Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue receive FDA 510(k) clearance?

Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue received FDA 510(k) clearance on 2024-06-20, under 510(k) number K241435.

Who is the listed applicant for Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue?

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 Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue?

The FDA product code for Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, co-braid-blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, blue; Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one MINITAPE suture, co-braid-blue is MBI.

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 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 0K252129AETOS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：MBI）

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。

K261869整潔式可收回式植入器插入器（6000127）Anika Therapeutics, Inc.K253065Aevumed SUPERCYNCH™按鈕系統Aevumed, Inc.K262809ArthroTAK 軟骨組織锚定組合包ArthroTAK, LLCK262677Iconix Knotless TRiverpoint MedicalK262047Grappler縫合釘系統Paragon 28, Inc.K262369AIR+ 全內側半月板修復設備，向上曲；AIR+ 全內側半月板修復設備，向下曲Stryker Endoscopy

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