FDA 510(k)

Augment 偏心儀器系統

K 號：K241043 · 2024-05-15

決定日期2024-05-15

產品代碼PHX

諮詢委員會或

決定相當於

器材摘要

Augment Off-Axis Instrument System is the device name listed in this FDA 510(k) record. The listed applicant is Fix Surgical. It received FDA 510(k) clearance on 2024-05-15 under 510(k) number K241043. The device is classified under product code PHX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Augment Off-Axis Instrument System?

Augment Off-Axis Instrument System is a medical device that received FDA 510(k) clearance on 2024-05-15. The listed applicant is Fix Surgical. The 510(k) number is K241043.

When did Augment Off-Axis Instrument System receive FDA 510(k) clearance?

Augment Off-Axis Instrument System received FDA 510(k) clearance on 2024-05-15, under 510(k) number K241043.

Who is the listed applicant for Augment Off-Axis Instrument System?

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

What is the FDA product code for Augment Off-Axis Instrument System?

The FDA product code for Augment Off-Axis Instrument System is PHX.

其他以 Fix Surgical 為申請人之記錄

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K233148Augment 偏心儀器系統

相關器械（代碼：PHX）

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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