FDA 510(k)

ROSA 部分膝關節系統

K 號：K210121 · 2021-04-19

決定日期2021-04-19

產品代碼OLO

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

ROSA Partial Knee 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 2021-04-19 under 510(k) number K210121. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ROSA Partial Knee System?

ROSA Partial Knee System is a medical device that received FDA 510(k) clearance on 2021-04-19. The listed applicant is Orthosoft D/B/A Zimmer Cas. The 510(k) number is K210121.

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

ROSA Partial Knee System received FDA 510(k) clearance on 2021-04-19, under 510(k) number K210121.

Who is the listed applicant for ROSA Partial Knee 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 Partial Knee System?

The FDA product code for ROSA Partial Knee System is OLO.

其他以 Orthosoft D/B/A Zimmer Cas 為申請人之記錄

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相關器械（代碼：OLO）

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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