FDA 510(k)

TDM板及螺釘系統

K 號：K190391 · 2019-11-15

決定日期2019-11-15

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

TDM Plate and Screw Systems 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 2019-11-15 under 510(k) number K190391. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TDM Plate and Screw Systems?

TDM Plate and Screw Systems is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K190391.

When did TDM Plate and Screw Systems receive FDA 510(k) clearance?

TDM Plate and Screw Systems received FDA 510(k) clearance on 2019-11-15, under 510(k) number K190391.

Who is the listed applicant for TDM Plate and Screw Systems?

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 TDM Plate and Screw Systems?

The FDA product code for TDM Plate and Screw Systems is HRS.

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。

K241128TDM板及螺釘系統 K230071大腿重建互锁釘系統、大腿逆向互锁釘系統、肱骨互锁釘系統、胫骨互锁釘系統、壓縮髋釘系統 K240423TDM 頸前板系統 K232115TDM大型骨板及螺釘系統 K231860TDM螺釘系統 K221844TDM腰椎間融合金層系統

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相關器械（代碼：HRS）

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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