FDA 510(k)

MOBIO 全膝关节系统后稳定（PS和PS+）胫骨植入物，MOBIO 全膝关节系统髌骨组件

K号: K183025 · 2019-01-28

决定日期2019-01-28

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： --- 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

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is the device name listed in this FDA 510(k) record. The listed applicant is B-One Ortho, Corp.. It received FDA 510(k) clearance on 2019-01-28 under 510(k) number K183025. 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 MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is a medical device that received FDA 510(k) clearance on 2019-01-28. The listed applicant is B-One Ortho, Corp.. The 510(k) number is K183025.

When did MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component receive FDA 510(k) clearance?

MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component received FDA 510(k) clearance on 2019-01-28, under 510(k) number K183025.

Who is the listed applicant for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

FDA 510(k)记录将B-One Ortho, Corp.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component?

The FDA product code for MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component is JWH.

列明B-One Ortho, Corp.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。

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 K253357b-ONE® 双极头部 K240528b-ONE® 全髋关节系统 K222431b-ONER MOBIO 全膝关节系统 K213673b-ONE MOBIO 全膝关节系统 K212912OneFix生物复合材料锚定器，OneFix生物复合材料小锚定器，OneFix所有缝合锚定器，OneFix干扰螺钉，OneFix套管系统

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官方来源

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