FDA 510(k)

4CIS 查里翁脊柱固定系統

K 號：K203233 · 2022-06-01

決定日期2022-06-01

產品代碼NKB

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決定相當於

器材摘要

4CIS Chiron Spinal Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Co., Ltd.. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K203233. 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 4CIS Chiron Spinal Fixation System?

4CIS Chiron Spinal Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is Solco Biomedical Co., Ltd.. The 510(k) number is K203233.

When did 4CIS Chiron Spinal Fixation System receive FDA 510(k) clearance?

4CIS Chiron Spinal Fixation System received FDA 510(k) clearance on 2022-06-01, under 510(k) number K203233.

Who is the listed applicant for 4CIS Chiron Spinal Fixation System?

The FDA 510(k) record lists Solco Biomedical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4CIS Chiron Spinal Fixation System?

The FDA product code for 4CIS Chiron Spinal Fixation System is NKB.

其他以 Solco Biomedical Co., Ltd. 為申請人之記錄

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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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