FDA 510(k)

OptiVu™ ROSA® MxR

K 號：K230567 · 2023-06-13

決定日期2023-06-13

產品代碼SBF

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

OptiVu™ ROSA® MxR is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). It received FDA 510(k) clearance on 2023-06-13 under 510(k) number K230567. The device is classified under product code SBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OptiVu™ ROSA® MxR?

OptiVu™ ROSA® MxR is a medical device that received FDA 510(k) clearance on 2023-06-13. The listed applicant is Orthosoft Inc (D/B/A Zimmer Cas). The 510(k) number is K230567.

When did OptiVu™ ROSA® MxR receive FDA 510(k) clearance?

OptiVu™ ROSA® MxR received FDA 510(k) clearance on 2023-06-13, under 510(k) number K230567.

Who is the listed applicant for OptiVu™ ROSA® MxR?

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

What is the FDA product code for OptiVu™ ROSA® MxR?

The FDA product code for OptiVu™ ROSA® MxR is SBF.

其他以 Orthosoft Inc (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。

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相關器械（代碼：SBF）

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。

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官方來源

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