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FDA 510(k)

NovoKnee (SteriKnee)

K 號：K261032 · 2026-04-27

申請人NovoSource
決定日期2026-04-27
產品代碼JWH
諮詢委員會或
決定相當於

器材摘要

NovoKnee (SteriKnee) is the device name listed in this FDA 510(k) record. The listed applicant is NovoSource. It received FDA 510(k) clearance on 2026-04-27 under 510(k) number K261032. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NovoKnee (SteriKnee)?

NovoKnee (SteriKnee) is a medical device that received FDA 510(k) clearance on 2026-04-27. The listed applicant is NovoSource. The 510(k) number is K261032.

When did NovoKnee (SteriKnee) receive FDA 510(k) clearance?

NovoKnee (SteriKnee) received FDA 510(k) clearance on 2026-04-27, under 510(k) number K261032.

Who is the listed applicant for NovoKnee (SteriKnee)?

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

What is the FDA product code for NovoKnee (SteriKnee)?

The FDA product code for NovoKnee (SteriKnee) is JWH.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：JWH）

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。

K262057GMK 扩充設備Medacta International SAK260063GSPE 分隔器The General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ 全膝系統Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝系統修復水泥固定胫骨增強器、樹枝擴展和壓入式樹枝擴展B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝關節系統Just Medical Devices (Tianjin) Co., Ltd.

官方來源

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