FDA 510(k)

OSSIOfiber® 鍵釘

K 號：K212594 · 2022-01-21

決定日期2022-01-21

產品代碼MNU

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器材摘要

OSSIOfiber® Staple is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K212594. The device is classified under product code MNU. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSSIOfiber® Staple?

OSSIOfiber® Staple is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is OSSIO , Ltd.. The 510(k) number is K212594.

When did OSSIOfiber® Staple receive FDA 510(k) clearance?

OSSIOfiber® Staple received FDA 510(k) clearance on 2022-01-21, under 510(k) number K212594.

Who is the listed applicant for OSSIOfiber® Staple?

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® Staple?

The FDA product code for OSSIOfiber® Staple is MNU.

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。

K254077OSSIOfiber® 穿釘可調節固定釘 K254055OSSIOfiber® 緝線墊板 K252022OSSIOfiber® 交叉螺釘 K251309OSSIOfiber® 緝線墊板 K243760OSSIOfiber® 緝線墊板 2.5-3.5 mm K241932OSSIOfiber® 压縮釘

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相關器械（代碼：MNU）

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。

K241932OSSIOfiber® 压縮釘OSSIO , Ltd.K233302OSSIOfiber® 压縮釘OSSIO , Ltd.

官方來源

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