FDA 510(k)

台灣解剖定位板及螺釘系統

K 號：K201229 · 2022-03-11

決定日期2022-03-11

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Intai Anatomic Locking Plate and Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Intai Technology Corporation. It received FDA 510(k) clearance on 2022-03-11 under 510(k) number K201229. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Intai Anatomic Locking Plate and Screw System?

Intai Anatomic Locking Plate and Screw System is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Intai Technology Corporation. The 510(k) number is K201229.

When did Intai Anatomic Locking Plate and Screw System receive FDA 510(k) clearance?

Intai Anatomic Locking Plate and Screw System received FDA 510(k) clearance on 2022-03-11, under 510(k) number K201229.

Who is the listed applicant for Intai Anatomic Locking Plate and Screw System?

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

What is the FDA product code for Intai Anatomic Locking Plate and Screw System?

The FDA product code for Intai Anatomic Locking Plate and Screw System is HRS.

其他以 Intai Technology Corporation 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。

K180523INTAI手術導航系統

相關器械（代碼：HRS）

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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