FDA 510(k)

Affixus® 自然钉® 近端肱骨系统

K号: K253749 · 2025-12-12

申请人Zimmer Switzerland Manufacturing GmbH

决定日期2025-12-12

产品代码HSB

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

Affixus® Natural Nail® Proximal Humeral System is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Switzerland Manufacturing GmbH. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K253749. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Affixus® Natural Nail® Proximal Humeral System?

Affixus® Natural Nail® Proximal Humeral System is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Zimmer Switzerland Manufacturing GmbH. The 510(k) number is K253749.

When did Affixus® Natural Nail® Proximal Humeral System receive FDA 510(k) clearance?

Affixus® Natural Nail® Proximal Humeral System received FDA 510(k) clearance on 2025-12-12, under 510(k) number K253749.

Who is the listed applicant for Affixus® Natural Nail® Proximal Humeral System?

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

What is the FDA product code for Affixus® Natural Nail® Proximal Humeral System?

The FDA product code for Affixus® Natural Nail® Proximal Humeral System is HSB.

列明Zimmer Switzerland Manufacturing GmbH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。

K241754NCB®多轴锁定接骨板系统；NCB®假体周围股骨接骨板系统；NCB®缆线按钮；NCB®直窄轴心接骨板 K231114Zimmer® 自然指甲® 系统颅骨髓内钉；Affixus® 自然指甲® 肱骨钉系统 K212129Persona®个性化膝关节系统

官方来源

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