FDA 510(k)

OSSIO™釘系列產品

K 號：K181180 · 2019-01-10

決定日期2019-01-10

產品代碼HTY

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決定相當於

器材摘要

OSSIO™ Pin Product Family is the device name listed in this FDA 510(k) record. The listed applicant is OSSIO , Ltd.. It received FDA 510(k) clearance on 2019-01-10 under 510(k) number K181180. 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 OSSIO™ Pin Product Family?

OSSIO™ Pin Product Family is a medical device that received FDA 510(k) clearance on 2019-01-10. The listed applicant is OSSIO , Ltd.. The 510(k) number is K181180.

When did OSSIO™ Pin Product Family receive FDA 510(k) clearance?

OSSIO™ Pin Product Family received FDA 510(k) clearance on 2019-01-10, under 510(k) number K181180.

Who is the listed applicant for OSSIO™ Pin Product Family?

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 OSSIO™ Pin Product Family?

The FDA product code for OSSIO™ Pin Product Family is HTY.

其他以 OSSIO , Ltd. 為申請人之記錄

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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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