FDA 510(k)

斷離螺釘系統

K 號：K172886 · 2017-12-20

決定日期2017-12-20

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

Breakaway Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Paragon 28. It received FDA 510(k) clearance on 2017-12-20 under 510(k) number K172886. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Breakaway Screw System?

Breakaway Screw System is a medical device that received FDA 510(k) clearance on 2017-12-20. The listed applicant is Paragon 28. The 510(k) number is K172886.

When did Breakaway Screw System receive FDA 510(k) clearance?

Breakaway Screw System received FDA 510(k) clearance on 2017-12-20, under 510(k) number K172886.

Who is the listed applicant for Breakaway Screw System?

The FDA 510(k) record lists Paragon 28 as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Breakaway Screw System?

The FDA product code for Breakaway Screw System is HRS.

其他以 Paragon 28 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：HRS）

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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