NovoKnee (SteriKnee)
K号: K261032 · 2026-04-27
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申请人NovoSource
决定日期2026-04-27
产品代码JWH
咨询委员会OR
请注意，由于原文中未提供具体的医疗设备监管文本，以下是一个示例翻译，您可以根据实际文本进行调整：
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产品名称：[产品名称]
公司名称：[公司名称]
根据FDA 510(k)预市场批准程序，[产品名称]已获得批准，用于[产品用途描述]。
产品注册号：[注册号]
PMA编号：[PMA编号]
临床试验编号（NCT）：[NCT编号]
PubMed ID（PMID）：[PMID编号]
更多信息请访问以下链接：
[URL]
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请将上述示例中的[产品名称]、[公司名称]、[注册号]、[PMA编号]、[NCT编号]、[PMID编号]和[URL]替换为实际的文本内容。
决定实质等同
器械摘要
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.
常见问题
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.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：JWH）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
K262057GMK 扩展Medacta International SAK260063GSPE间隔器The General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ 全膝关节系统Suzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ 全膝关节系统翻修水泥固定胫骨增强器、干骺端延长器和压配合干骺端延长器B-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK膝关节系统Just Medical Devices (Tianjin) Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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