FDA 510(k)

NAVIPLAN - 全髋關節置換用CT計劃軟體

K 號：K211429 · 2021-10-05

決定日期2021-10-05

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

NAVIPLAN - CT Planning Software for Total Hip Replacement is the device name listed in this FDA 510(k) record. The listed applicant is Naviswiss AG. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K211429. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NAVIPLAN - CT Planning Software for Total Hip Replacement?

NAVIPLAN - CT Planning Software for Total Hip Replacement is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Naviswiss AG. The 510(k) number is K211429.

When did NAVIPLAN - CT Planning Software for Total Hip Replacement receive FDA 510(k) clearance?

NAVIPLAN - CT Planning Software for Total Hip Replacement received FDA 510(k) clearance on 2021-10-05, under 510(k) number K211429.

Who is the listed applicant for NAVIPLAN - CT Planning Software for Total Hip Replacement?

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

What is the FDA product code for NAVIPLAN - CT Planning Software for Total Hip Replacement?

The FDA product code for NAVIPLAN - CT Planning Software for Total Hip Replacement is LLZ.

其他以 Naviswiss AG 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。

K223351Naviswiss 髋關節 K193094Naviswiss 髋關節導航系統

相關器械（代碼：LLZ）

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。

K261874Syneris PACS v.1.0.1.0Syneris K262442HipStudio分析Replasia BV K261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

官方來源

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