FDA 510(k)

SF 推入式固定釘

K 號：K260294 · 2026-03-27

決定日期2026-03-27

產品代碼MAI

諮詢委員會或

決定相當於

器材摘要

SF Push-in Anchor is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Fusion Technologies GmbH. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K260294. 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 SF Push-in Anchor?

SF Push-in Anchor is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Surgical Fusion Technologies GmbH. The 510(k) number is K260294.

When did SF Push-in Anchor receive FDA 510(k) clearance?

SF Push-in Anchor received FDA 510(k) clearance on 2026-03-27, under 510(k) number K260294.

Who is the listed applicant for SF Push-in Anchor?

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

What is the FDA product code for SF Push-in Anchor?

The FDA product code for SF Push-in Anchor is MAI.

其他以 Surgical Fusion Technologies GmbH 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。

K240288SF 推入式夾緊釘

相關器械（代碼：MAI）

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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