FDA 510(k)

Medline UNITE® 数字融合螺钉系统

K号: K211944 · 2021-07-22

决定日期2021-07-22

产品代码HWC

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

Medline UNITE® Digital Fusion Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Medline Industries, Inc.. It received FDA 510(k) clearance on 2021-07-22 under 510(k) number K211944. 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.

常见问题

What is the Medline UNITE® Digital Fusion Screw System?

Medline UNITE® Digital Fusion Screw System is a medical device that received FDA 510(k) clearance on 2021-07-22. The listed applicant is Medline Industries, Inc.. The 510(k) number is K211944.

When did Medline UNITE® Digital Fusion Screw System receive FDA 510(k) clearance?

Medline UNITE® Digital Fusion Screw System received FDA 510(k) clearance on 2021-07-22, under 510(k) number K211944.

Who is the listed applicant for Medline UNITE® Digital Fusion Screw System?

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

What is the FDA product code for Medline UNITE® Digital Fusion Screw System?

The FDA product code for Medline UNITE® Digital Fusion Screw System is HWC. This falls under the Cardiovascular category.

列明Medline Industries, 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。

K230559Hudson RCI® 4 PSI 压力释放阀的 disposable 加湿器（3230），Hudson RCI® 6 PSI 压力释放阀的 disposable 加湿器（3260）K223100Hudson RCI AquaTherm III Plus 外部可调电子加热器（050-14）K222665Medline UNITE® 踝关节融合接骨板系统 K213054Medline Sure-Snap安全注射针，Medline Sure-Snap安全注射器 K212911Konig Mogen 夹 K220565Hudson RCI Triflo II 激励深呼吸训练器

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官方来源

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