FDA 510(k)

OSSIOfiber® 緝線墊板 2.5-3.5 mm

K 號：K243760 · 2025-04-03

決定日期2025-04-03

產品代碼MAI

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決定相當於

器材摘要

OSSIOfiber® Suture Anchor 2.5-3.5 mm is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2025-04-03 under 510(k) number K243760. 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 OSSIOfiber® Suture Anchor 2.5-3.5 mm?

OSSIOfiber® Suture Anchor 2.5-3.5 mm is a medical device that received FDA 510(k) clearance on 2025-04-03. The listed applicant is OSSIO , Ltd.. The 510(k) number is K243760.

When did OSSIOfiber® Suture Anchor 2.5-3.5 mm receive FDA 510(k) clearance?

OSSIOfiber® Suture Anchor 2.5-3.5 mm received FDA 510(k) clearance on 2025-04-03, under 510(k) number K243760.

Who is the listed applicant for OSSIOfiber® Suture Anchor 2.5-3.5 mm?

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

What is the FDA product code for OSSIOfiber® Suture Anchor 2.5-3.5 mm?

The FDA product code for OSSIOfiber® Suture Anchor 2.5-3.5 mm is MAI.

其他以 OSSIO , Ltd. 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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