FDA 510(k)

電子骨科肩關節軟體

K 號：K201928 · 2020-09-30

決定日期2020-09-30

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

e-Ortho Shoulder Software is the device name listed in this FDA 510(k) record. The listed applicant is FH Industrie. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K201928. 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 e-Ortho Shoulder Software?

e-Ortho Shoulder Software is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is FH Industrie. The 510(k) number is K201928.

When did e-Ortho Shoulder Software receive FDA 510(k) clearance?

e-Ortho Shoulder Software received FDA 510(k) clearance on 2020-09-30, under 510(k) number K201928.

Who is the listed applicant for e-Ortho Shoulder Software?

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

What is the FDA product code for e-Ortho Shoulder Software?

The FDA product code for e-Ortho Shoulder Software is LLZ.

其他以 FH Industrie 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。

K254003JARVIS 骨幹移植體 K253345JARVIS 骨幹標準管 K252411JARVIS 閃淚肩關逆轉人工關節 K242253JARVIS 閃淚肩關逆轉人工關節 K232226ARROW 偏心肱骨插入物 K220758e-Ortho Shoulder 軟體 v1.1

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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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