FDA 510(k)

TDM 頸前板系統

K 號：K240423 · 2024-04-08

決定日期2024-04-08

產品代碼KWQ

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決定相當於

器材摘要

TDM Anterior Cervical Plate 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 2024-04-08 under 510(k) number K240423. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TDM Anterior Cervical Plate System?

TDM Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2024-04-08. The listed applicant is Tdm Co., Ltd.. The 510(k) number is K240423.

When did TDM Anterior Cervical Plate System receive FDA 510(k) clearance?

TDM Anterior Cervical Plate System received FDA 510(k) clearance on 2024-04-08, under 510(k) number K240423.

Who is the listed applicant for TDM Anterior Cervical Plate 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 TDM Anterior Cervical Plate System?

The FDA product code for TDM Anterior Cervical Plate System is KWQ.

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 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 K220285PINE椎板螺釘系統

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相關器械（代碼：KWQ）

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。

K262149corra®脊椎板系統Carlsmed, Inc.K261309Palisades™ 壁壘板系統Bethesda Medical Devices, LLC K252776ARIES 前頸椎板系統ZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P 頸椎前方板系統L&K BIOMED Co., Ltd.K260570corra™脊椎板系統Carlsmed, Inc.K260697VyPlate™ 頸椎前方板系統Vy Spine, LLC

官方來源

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