FDA 510(k)

COSY 頸胸顱骨棒釘系統

K 號：K220658 · 2022-11-18

決定日期2022-11-18

產品代碼NKG

諮詢委員會或

決定相當於

器材摘要

COSY Cervicothoracic Occipital Rod-Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Signus Medizintechnik GmbH. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K220658. The device is classified under product code NKG. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the COSY Cervicothoracic Occipital Rod-Screw System?

COSY Cervicothoracic Occipital Rod-Screw System is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Signus Medizintechnik GmbH. The 510(k) number is K220658.

When did COSY Cervicothoracic Occipital Rod-Screw System receive FDA 510(k) clearance?

COSY Cervicothoracic Occipital Rod-Screw System received FDA 510(k) clearance on 2022-11-18, under 510(k) number K220658.

Who is the listed applicant for COSY Cervicothoracic Occipital Rod-Screw System?

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

What is the FDA product code for COSY Cervicothoracic Occipital Rod-Screw System?

The FDA product code for COSY Cervicothoracic Occipital Rod-Screw System is NKG.

其他以 Signus Medizintechnik GmbH 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：NKG）

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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