FDA 510(k)

STERN FIX 胸骨固定系統

K 號：K221795 · 2022-10-19

決定日期2022-10-19

產品代碼JDQ

諮詢委員會或

決定相當於

器材摘要

STERN FIX Sternal Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is Neos Surgery S.L. It received FDA 510(k) clearance on 2022-10-19 under 510(k) number K221795. The device is classified under product code JDQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STERN FIX Sternal Stabilization System?

STERN FIX Sternal Stabilization System is a medical device that received FDA 510(k) clearance on 2022-10-19. The listed applicant is Neos Surgery S.L. The 510(k) number is K221795.

When did STERN FIX Sternal Stabilization System receive FDA 510(k) clearance?

STERN FIX Sternal Stabilization System received FDA 510(k) clearance on 2022-10-19, under 510(k) number K221795.

Who is the listed applicant for STERN FIX Sternal Stabilization System?

The FDA 510(k) record lists Neos Surgery S.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERN FIX Sternal Stabilization System?

The FDA product code for STERN FIX Sternal Stabilization System is JDQ.

其他以 Neos Surgery S.L 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。

K240137頭蓋 LOOP，頭蓋 LOOP L 和頭蓋 LOOP XL 頭蓋骨固定系統 K211613Stern Fix 胸骨固定系統 K160739頭部蓋

相關器械（代碼：JDQ）

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。

K261271Cable-Ready® 線材夾緊系統Pioneer Surgical Technology, Inc.K243905縫合環繞器 – 缝合膠帶GM Dos Reis Industria e Comercio Ltda.K243344Arthrex 纤維膠帶及虎膠帶纏繞縫線；Arthrex 放射不透明纖維膠帶纏繞縫線Arthrex, Inc.K232733Mbrace 線材Medacta International S.A.K233949ACCORD 線路系統Smith & Nephew, Inc.K232986VariTrax 胸骨環固定系統Circumfix Solutions, Inc.

官方來源

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