FDA 510(k)

Q-FIX ULTRA 全縫線固定釘

K 號：K232457 · 2023-09-08

決定日期2023-09-08

產品代碼MBI

諮詢委員會或

決定相當於

器材摘要

Q-FIX ULTRA All-Suture Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K232457. 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 ULTRA All-Suture Anchor?

Q-FIX ULTRA All-Suture Anchor is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is Smith & Nephew. The 510(k) number is K232457.

When did Q-FIX ULTRA All-Suture Anchor receive FDA 510(k) clearance?

Q-FIX ULTRA All-Suture Anchor received FDA 510(k) clearance on 2023-09-08, under 510(k) number K232457.

Who is the listed applicant for Q-FIX ULTRA All-Suture Anchor?

The FDA 510(k) record lists Smith & Nephew as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-FIX ULTRA All-Suture Anchor?

The FDA product code for Q-FIX ULTRA All-Suture Anchor is MBI.

其他以 Smith & Nephew 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。

K241666EVOS 骨盆及骨盂系統 K240487EVOS 閃光板 K233730Footprint Mini PK, 3.5mm 緝合釘 K223762史密斯與內夫ACCORD™ 線路系統 K203566藥丸應用程序 K201253模組化軌道系統，TAYLOR 空間架外固定器，JET-X 外固定器，伊利扎羅夫外固定器，其他外固定器

查看所有 15 項裝置 →

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, LLC K262677Iconix Knotless TRiverpoint Medical K262047Grappler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

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。