FDA 510(k)

Syntec 髋部釘系統

K 號：K181296 · 2019-04-11

決定日期2019-04-11

產品代碼HSB

諮詢委員會或

決定相當於

器材摘要

Syntec Femoral Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K181296. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Syntec Femoral Nail System?

Syntec Femoral Nail System is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K181296.

When did Syntec Femoral Nail System receive FDA 510(k) clearance?

Syntec Femoral Nail System received FDA 510(k) clearance on 2019-04-11, under 510(k) number K181296.

Who is the listed applicant for Syntec Femoral Nail System?

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

What is the FDA product code for Syntec Femoral Nail System?

The FDA product code for Syntec Femoral Nail System is HSB.

其他以 Syntec Scientific Corporation 為申請人之記錄

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相關器械（代碼：HSB）

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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