FDA 510(k)

TITAN指甲針；APTUS K針系統

K 號：K260934 · 2026-04-17

決定日期2026-04-17

產品代碼HWC

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決定相當於

器材摘要

TITAN Nail; APTUS K-Wire System is the device name listed in this FDA 510(k) record. The listed applicant is Medartis AG. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K260934. 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 TITAN Nail; APTUS K-Wire System?

TITAN Nail; APTUS K-Wire System is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Medartis AG. The 510(k) number is K260934.

When did TITAN Nail; APTUS K-Wire System receive FDA 510(k) clearance?

TITAN Nail; APTUS K-Wire System received FDA 510(k) clearance on 2026-04-17, under 510(k) number K260934.

Who is the listed applicant for TITAN Nail; APTUS K-Wire System?

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

What is the FDA product code for TITAN Nail; APTUS K-Wire System?

The FDA product code for TITAN Nail; APTUS K-Wire System is HWC. This falls under the Cardiovascular category.

其他以 Medartis AG 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。

K260761APTUS 肩胛骨系統 2.8 K253916APTUS Shoulder Proximal Humerus System, PentaLock 3.5 K243610APTUS 手部系統; APTUS 肘部背側桡骨頭板 K240613APTUS 肘部背側桡骨頭板 K232105APTUS 足部系統 2.8-3.5 K234062APTUS 手部舟狀骨板

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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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