FDA 510(k)

Mako 全膝應用程序（3.0）；雜合針尖指針

K 號：K250608 · 2025-04-25

決定日期2025-04-25

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

Mako Total Knee Application (3.0); Hybrid Tip Pointer is the device name listed in this FDA 510(k) record. The listed applicant is Mako Surgical Corp.. It received FDA 510(k) clearance on 2025-04-25 under 510(k) number K250608. 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 Mako Total Knee Application (3.0); Hybrid Tip Pointer?

Mako Total Knee Application (3.0); Hybrid Tip Pointer is a medical device that received FDA 510(k) clearance on 2025-04-25. The listed applicant is Mako Surgical Corp.. The 510(k) number is K250608.

When did Mako Total Knee Application (3.0); Hybrid Tip Pointer receive FDA 510(k) clearance?

Mako Total Knee Application (3.0); Hybrid Tip Pointer received FDA 510(k) clearance on 2025-04-25, under 510(k) number K250608.

Who is the listed applicant for Mako Total Knee Application (3.0); Hybrid Tip Pointer?

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

What is the FDA product code for Mako Total Knee Application (3.0); Hybrid Tip Pointer?

The FDA product code for Mako Total Knee Application (3.0); Hybrid Tip Pointer is OLO.

其他以 Mako Surgical Corp. 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：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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