FDA 510(k)

Treace醫學概念（TMC）內植固定系統

K 號：K222645 · 2022-11-21

決定日期2022-11-21

產品代碼JDR

諮詢委員會或

決定相當於

器材摘要

Treace Medical Concepts (TMC) Implant Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts. It received FDA 510(k) clearance on 2022-11-21 under 510(k) number K222645. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Treace Medical Concepts (TMC) Implant Fixation System?

Treace Medical Concepts (TMC) Implant Fixation System is a medical device that received FDA 510(k) clearance on 2022-11-21. The listed applicant is Treace Medical Concepts. The 510(k) number is K222645.

When did Treace Medical Concepts (TMC) Implant Fixation System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Implant Fixation System received FDA 510(k) clearance on 2022-11-21, under 510(k) number K222645.

Who is the listed applicant for Treace Medical Concepts (TMC) Implant Fixation System?

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

What is the FDA product code for Treace Medical Concepts (TMC) Implant Fixation System?

The FDA product code for Treace Medical Concepts (TMC) Implant Fixation System is JDR.

其他以 Treace Medical Concepts 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。

K251135Treace醫學概念（TMC）內植固定系統 K243658TMC壓力植入系統 K242415TMC壓力植入系統 K232387Treace醫學概念（TMC）壓力植入系統

相關器械（代碼：JDR）

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。

K262451Arthrex DynaNite 针Arthrex, Inc.K261121巨牙動態壓縮系統Paragon 28, Inc.K250712連結壓縮釘針系統Trax Surgical K243888Medline UNITE® REFLEX® 混合不銹鋼植入系統Medline Industries, LP K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC壓力植入系統Treace Medical Concepts

官方來源

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