FDA 510(k)

T2 Plus

K 號：K233806 · 2024-09-06

決定日期2024-09-06

產品代碼OAS

諮詢委員會RA

決定相當於

器材摘要

T2 Plus is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) number K233806. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the T2 Plus?

T2 Plus is a medical device that received FDA 510(k) clearance on 2024-09-06. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K233806.

When did T2 Plus receive FDA 510(k) clearance?

T2 Plus received FDA 510(k) clearance on 2024-09-06, under 510(k) number K233806.

Who is the listed applicant for T2 Plus?

The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T2 Plus?

The FDA product code for T2 Plus is OAS.

其他以 Osstem Implant Co., Ltd. 為申請人之記錄

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