FDA 510(k)

ConfoMIS iTotal Cruciate Retaining (CR) 膝关节置换系统（iTotal CR KRS）

K号: K161366 · 2016-06-14

决定日期2016-06-14

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

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is the device name listed in this FDA 510(k) record. The listed applicant is Conformis, Inc.. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K161366. 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 ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is Conformis, Inc.. The 510(k) number is K161366.

When did ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) receive FDA 510(k) clearance?

ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) received FDA 510(k) clearance on 2016-06-14, under 510(k) number K161366.

Who is the listed applicant for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

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

What is the FDA product code for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS)?

The FDA product code for ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) is JWH.

列明Conformis, 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。

K232426Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts K223316Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System K230846iTotal身份膝关节置换系统；Identity Imprint膝关节置换系统 K231233Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS K231178ACTERA™ 髋关节系统 K230844Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert

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