FDA 510(k)

ELEOS™ 配备NanoCept®技术肢体挽救系统

K号: K253066 · 2026-06-08

决定日期2026-06-08

产品代码QZZ

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： --- 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] --- 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

ELEOS™ with NanoCept® Technology Limb Salvage System is the device name listed in this FDA 510(k) record. The listed applicant is Onkos Surgical, Inc.. It received FDA 510(k) clearance on 2026-06-08 under 510(k) number K253066. The device is classified under product code QZZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELEOS™ with NanoCept® Technology Limb Salvage System?

ELEOS™ with NanoCept® Technology Limb Salvage System is a medical device that received FDA 510(k) clearance on 2026-06-08. The listed applicant is Onkos Surgical, Inc.. The 510(k) number is K253066.

When did ELEOS™ with NanoCept® Technology Limb Salvage System receive FDA 510(k) clearance?

ELEOS™ with NanoCept® Technology Limb Salvage System received FDA 510(k) clearance on 2026-06-08, under 510(k) number K253066.

Who is the listed applicant for ELEOS™ with NanoCept® Technology Limb Salvage System?

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

What is the FDA product code for ELEOS™ with NanoCept® Technology Limb Salvage System?

The FDA product code for ELEOS™ with NanoCept® Technology Limb Salvage System is QZZ.

列明Onkos Surgical, Inc.为申报人的其他记录

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。

K252920ELEOS™ 肢体挽救系统配备NanoCept®技术 K223348My3D®个性化骨盆重建 K180130ELEOS™ 双极骨盆系统 K161520ELEOS 肢体挽救系统

官方来源

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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。