FDA 510(k)

AnyPlus® 腰椎固定系統

K 號：K172546 · 2017-10-23

決定日期2017-10-23

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

AnyPlus® Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is GS Medical Co., Ltd.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172546. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AnyPlus® Spinal Fixation System?

AnyPlus® Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is GS Medical Co., Ltd.. The 510(k) number is K172546.

When did AnyPlus® Spinal Fixation System receive FDA 510(k) clearance?

AnyPlus® Spinal Fixation System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172546.

Who is the listed applicant for AnyPlus® Spinal Fixation System?

FDA 510(k)記錄將GS Medical Co., Ltd.列為申請人。這本身並不足以確立設備製造商。

What is the FDA product code for AnyPlus® Spinal Fixation System?

The FDA product code for AnyPlus® Spinal Fixation System is NKB.

其他以 GS Medical Co., 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。

K254260VEGA 子宮頸螺釘系統 K243073AnyPlus Navigated Instruments System K241738PYXIS 3D 鈦金屬頸椎金屬支架系統 K240350AnyPlus II 腰椎固定系統 K231808QUASAR 独立式 ACIF 系統 K223868PYXIS 3D 鈦金屬籠架系統

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相關器械（代碼：NKB）

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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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。