FDA 510(k)

OSSIOfiber® 穿刺可調節固定釘

K 號：K230750 · 2023-09-13

決定日期2023-09-13

產品代碼HTY

諮詢委員會或

決定相當於

器材摘要

OSSIOfiber® Cannulated Trimmable Fixation Nail is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2023-09-13 under 510(k) number K230750. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the OSSIOfiber® Cannulated Trimmable Fixation Nail?

OSSIOfiber® Cannulated Trimmable Fixation Nail is a medical device that received FDA 510(k) clearance on 2023-09-13. The listed applicant is OSSIO , Ltd.. The 510(k) number is K230750.

When did OSSIOfiber® Cannulated Trimmable Fixation Nail receive FDA 510(k) clearance?

OSSIOfiber® Cannulated Trimmable Fixation Nail received FDA 510(k) clearance on 2023-09-13, under 510(k) number K230750.

Who is the listed applicant for OSSIOfiber® Cannulated Trimmable Fixation Nail?

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® Cannulated Trimmable Fixation Nail?

The FDA product code for OSSIOfiber® Cannulated Trimmable Fixation Nail is HTY.

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：HTY）

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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