FDA 510(k)

改革椎板螺釘系統

K 號：K200303 · 2020-05-19

決定日期2020-05-19

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

Reform Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Precision Spine. It received FDA 510(k) clearance on 2020-05-19 under 510(k) number K200303. 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 Reform Pedicle Screw System?

Reform Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2020-05-19. The listed applicant is Precision Spine. The 510(k) number is K200303.

When did Reform Pedicle Screw System receive FDA 510(k) clearance?

Reform Pedicle Screw System received FDA 510(k) clearance on 2020-05-19, under 510(k) number K200303.

Who is the listed applicant for Reform Pedicle Screw System?

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

What is the FDA product code for Reform Pedicle Screw System?

The FDA product code for Reform Pedicle Screw System is NKB.

其他以 Precision Spine 為申請人之記錄

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K192494NexGen 前頸椎板系統

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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