FDA 510(k)

Biosteon® 螺釘

K 號：K251680 · 2026-02-17

決定日期2026-02-17

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

Biosteon® Screw is the device name listed in this FDA 510(k) record. The listed applicant is Biocomposites, Ltd.. It received FDA 510(k) clearance on 2026-02-17 under 510(k) number K251680. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Biosteon® Screw?

Biosteon® Screw is a medical device that received FDA 510(k) clearance on 2026-02-17. The listed applicant is Biocomposites, Ltd.. The 510(k) number is K251680.

When did Biosteon® Screw receive FDA 510(k) clearance?

Biosteon® Screw received FDA 510(k) clearance on 2026-02-17, under 510(k) number K251680.

Who is the listed applicant for Biosteon® Screw?

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

What is the FDA product code for Biosteon® Screw?

The FDA product code for Biosteon® Screw is MAI.

其他以 Biocomposites, Ltd. 為申請人之記錄

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