FDA 510(k)

泰柏醫療創傷螺釘

K 號：K252901 · 2025-12-31

決定日期2025-12-31

產品代碼HWC

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決定相當於

器材摘要

Tyber Medical Trauma Screw is the device name listed in this FDA 510(k) record. The listed applicant is Tyber Medical, LLC. It received FDA 510(k) clearance on 2025-12-31 under 510(k) number K252901. 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 Tyber Medical Trauma Screw?

Tyber Medical Trauma Screw is a medical device that received FDA 510(k) clearance on 2025-12-31. The listed applicant is Tyber Medical, LLC. The 510(k) number is K252901.

When did Tyber Medical Trauma Screw receive FDA 510(k) clearance?

Tyber Medical Trauma Screw received FDA 510(k) clearance on 2025-12-31, under 510(k) number K252901.

Who is the listed applicant for Tyber Medical Trauma Screw?

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

What is the FDA product code for Tyber Medical Trauma Screw?

The FDA product code for Tyber Medical Trauma Screw is HWC. This falls under the Cardiovascular category.

其他以 Tyber Medical, LLC 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：HWC）

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。

K262975Arthrex Beaming系統Arthrex, Inc.K260995DynaNail螺旋®固定系統MedShape, Inc.K254280F.A.S.T. 螺釘Steps Ortho K261057ActivaScrew™ 穿刺式 COMBioretec, Ltd.K260106OsteoCoil™ GT 活動壓縮系統Flower Orthopedics Corporation DBA Conventus Flower Orthoped K262344大型壓縮螺釘TriMed, Inc.

官方來源

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