FDA 510(k)

PINE椎板螺釘系統

K 號：K220285 · 2022-05-19

決定日期2022-05-19

產品代碼NKB

諮詢委員會或

決定相當於

器材摘要

PINE Pedicle Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Tdm Co., Ltd.. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K220285. 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 PINE Pedicle Screw System?

PINE Pedicle Screw System is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K220285.

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

PINE Pedicle Screw System received FDA 510(k) clearance on 2022-05-19, under 510(k) number K220285.

Who is the listed applicant for PINE Pedicle Screw System?

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

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

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

其他以 Tdm 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。

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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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