FDA 510(k)

Auxein 钉固定系統

K 號：K210792 · 2021-08-25

決定日期2021-08-25

產品代碼HWC

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器材摘要

Auxein Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is Auxein Medical Private Limited. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K210792. 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 Auxein Nailing System?

Auxein Nailing System is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Auxein Medical Private Limited. The 510(k) number is K210792.

When did Auxein Nailing System receive FDA 510(k) clearance?

Auxein Nailing System received FDA 510(k) clearance on 2021-08-25, under 510(k) number K210792.

Who is the listed applicant for Auxein Nailing System?

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

What is the FDA product code for Auxein Nailing System?

The FDA product code for Auxein Nailing System is HWC. This falls under the Cardiovascular category.

其他以 Auxein Medical Private Limited 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。

K221787Auxein 的 DHS/DCS 板系統 K213059胫骨及排骨系統 K213110AUXILOCK PEEK OPTIMA 螺釘內縫合針，AUXILOCK ROTADOR PEEK OPTIMA 螺釘內縫合針 K213018Auxilock GFS Mini, GFS II 大型, 和 GFS Ultimate K213108肱骨與尺骨系統 K213014Varixis 肘關節系統

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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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