FDA 510(k)

G3™ 活動板(R) 小碎片系統

K 號：K160633 · 2016-04-22

決定日期2016-04-22

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

G3(TM) Active Plate(R) Small Fragment System is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Fracture Care, Inc.. It received FDA 510(k) clearance on 2016-04-22 under 510(k) number K160633. 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 G3(TM) Active Plate(R) Small Fragment System?

G3(TM) Active Plate(R) Small Fragment System is a medical device that received FDA 510(k) clearance on 2016-04-22. The listed applicant is Genesis Fracture Care, Inc.. The 510(k) number is K160633.

When did G3(TM) Active Plate(R) Small Fragment System receive FDA 510(k) clearance?

G3(TM) Active Plate(R) Small Fragment System received FDA 510(k) clearance on 2016-04-22, under 510(k) number K160633.

Who is the listed applicant for G3(TM) Active Plate(R) Small Fragment System?

The FDA 510(k) record lists Genesis Fracture Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for G3(TM) Active Plate(R) Small Fragment System?

The FDA product code for G3(TM) Active Plate(R) Small Fragment System is HRS.

其他以 Genesis Fracture Care, Inc. 為申請人之記錄

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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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