FDA 510(k)

矯正醫療設備規範文本翻譯：矯正醫療設備迷你螺釘延長系統

K 號：K202790 · 2021-09-17

決定日期2021-09-17

產品代碼OAT

諮詢委員會DE

決定相當於

器材摘要

Syntec Orthodontic Mini Screw Extended System is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2021-09-17 under 510(k) number K202790. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Syntec Orthodontic Mini Screw Extended System?

Syntec Orthodontic Mini Screw Extended System is a medical device that received FDA 510(k) clearance on 2021-09-17. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K202790.

When did Syntec Orthodontic Mini Screw Extended System receive FDA 510(k) clearance?

Syntec Orthodontic Mini Screw Extended System received FDA 510(k) clearance on 2021-09-17, under 510(k) number K202790.

Who is the listed applicant for Syntec Orthodontic Mini Screw Extended System?

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

What is the FDA product code for Syntec Orthodontic Mini Screw Extended System?

The FDA product code for Syntec Orthodontic Mini Screw Extended System is OAT.

其他以 Syntec Scientific 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。

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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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