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FDA 510(k)

Treace醫學概念（TMC）快拆螺釘系統

K 號：K183363 · 2019-06-13

申請人Treace Medical Concepts, Inc.
決定日期2019-06-13
產品代碼HWC
諮詢委員會或
決定相當於

器材摘要

Treace Medical Concepts (TMC) Snap-Off Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Treace Medical Concepts, Inc.. It received FDA 510(k) clearance on 2019-06-13 under 510(k) number K183363. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the Treace Medical Concepts (TMC) Snap-Off Screw System?

Treace Medical Concepts (TMC) Snap-Off Screw System is a medical device that received FDA 510(k) clearance on 2019-06-13. The listed applicant is Treace Medical Concepts, Inc.. The 510(k) number is K183363.

When did Treace Medical Concepts (TMC) Snap-Off Screw System receive FDA 510(k) clearance?

Treace Medical Concepts (TMC) Snap-Off Screw System received FDA 510(k) clearance on 2019-06-13, under 510(k) number K183363.

Who is the listed applicant for Treace Medical Concepts (TMC) Snap-Off Screw System?

FDA 510(k) 記錄將 Treace Medical Concepts, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Treace Medical Concepts (TMC) Snap-Off Screw System?

The FDA product code for Treace Medical Concepts (TMC) Snap-Off Screw System is HWC. This falls under the Cardiovascular category.

相關臨床試驗

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其他以 Treace Medical Concepts, Inc. 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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