Active-X Total Knee System
K号: K160159 · 2016-09-06
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器械摘要
Active-X Total Knee System is the device name listed in this FDA 510(k) record. The listed applicant is Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2016-09-06 under 510(k) number K160159. 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 Active-X Total Knee System?
Active-X Total Knee System is a medical device that received FDA 510(k) clearance on 2016-09-06. The listed applicant is Signature Orthopaedics Pty, Ltd.. The 510(k) number is K160159.
When did Active-X Total Knee System receive FDA 510(k) clearance?
Active-X Total Knee System received FDA 510(k) clearance on 2016-09-06, under 510(k) number K160159.
Who is the listed applicant for Active-X Total Knee System?
The FDA 510(k) record lists Signature Orthopaedics Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Active-X Total Knee System?
The FDA product code for Active-X Total Knee System is JWH.
相关临床试验
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。
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列明Signature Orthopaedics Pty, Ltd.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。
相关器械（代码：JWH）
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。
K262057GMK ExtensionMedacta International SAK260063GSPE SpacerThe General Hospital Corporation, d/b/a MassachusettsK262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.
官方来源
在 FDA 数据库中查看 →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。
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