FDA 510(k)

ROSA 髋關節系統

K 號：K210998 · 2021-08-17

決定日期2021-08-17

產品代碼LLZ

諮詢委員會RA

決定相當於

器材摘要

ROSA Hip System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft D/B/A Zimmer Cas. It received FDA 510(k) clearance on 2021-08-17 under 510(k) number K210998. 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 ROSA Hip System?

ROSA Hip System is a medical device that received FDA 510(k) clearance on 2021-08-17. The listed applicant is Orthosoft D/B/A Zimmer Cas. The 510(k) number is K210998.

When did ROSA Hip System receive FDA 510(k) clearance?

ROSA Hip System received FDA 510(k) clearance on 2021-08-17, under 510(k) number K210998.

Who is the listed applicant for ROSA Hip System?

The FDA 510(k) record lists Orthosoft D/B/A Zimmer Cas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSA Hip System?

The FDA product code for ROSA Hip System is LLZ.

其他以 Orthosoft D/B/A Zimmer Cas 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。

K232533ROSA 部分膝關節系統 K230243ROSA® 髋關節系統 K221928ROSA® 髋關節系統 K213033iASSIST 適合膝關節系統 K210653一計劃者臀部設備 K210121ROSA 部分膝關節系統

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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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