FDA 510(k)

JASPER脊椎固定系統II

K 號：K190762 · 2019-06-19

決定日期2019-06-19

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

The JASPER Spinal Fixation System II is the device name listed in this FDA 510(k) record. The listed applicant is Gbs Commonwealth Co., Ltd.. It received FDA 510(k) clearance on 2019-06-19 under 510(k) number K190762. 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 The JASPER Spinal Fixation System II?

The JASPER Spinal Fixation System II is a medical device that received FDA 510(k) clearance on 2019-06-19. The listed applicant is Gbs Commonwealth Co., Ltd.. The 510(k) number is K190762.

When did The JASPER Spinal Fixation System II receive FDA 510(k) clearance?

The JASPER Spinal Fixation System II received FDA 510(k) clearance on 2019-06-19, under 510(k) number K190762.

Who is the listed applicant for The JASPER Spinal Fixation System II?

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

What is the FDA product code for The JASPER Spinal Fixation System II?

The FDA product code for The JASPER Spinal Fixation System II is NKB.

其他以 Gbs Commonwealth 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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