FDA 510(k)

ROSA® 肩關節系統

K 號：K260582 · 2026-05-21

決定日期2026-05-21

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® Shoulder System 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 2026-05-21 under 510(k) number K260582. 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® Shoulder System?

ROSA® Shoulder System is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K260582.

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

ROSA® Shoulder System received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260582.

Who is the listed applicant for ROSA® Shoulder System?

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 ROSA® Shoulder System?

The FDA product code for ROSA® Shoulder System is OLO.

其他以 Orthosoft Inc. (d/b/a) Zimmer CAS 為申請人之記錄

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相關器械（代碼：OLO）

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官方來源

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