Pro-Link® Stand-Alone Cervical Spacer System
K号: K160066 · 2016-09-02
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器械摘要
Pro-Link® Stand-Alone Cervical Spacer System is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine, Inc.. It received FDA 510(k) clearance on 2016-09-02 under 510(k) number K160066. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Pro-Link® Stand-Alone Cervical Spacer System?
Pro-Link® Stand-Alone Cervical Spacer System is a medical device that received FDA 510(k) clearance on 2016-09-02. The listed applicant is Life Spine, Inc.. The 510(k) number is K160066.
When did Pro-Link® Stand-Alone Cervical Spacer System receive FDA 510(k) clearance?
Pro-Link® Stand-Alone Cervical Spacer System received FDA 510(k) clearance on 2016-09-02, under 510(k) number K160066.
Who is the listed applicant for Pro-Link® Stand-Alone Cervical Spacer System?
The FDA 510(k) record lists Life Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pro-Link® Stand-Alone Cervical Spacer System?
The FDA product code for Pro-Link® Stand-Alone Cervical Spacer System is OVE.
相关临床试验
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列明Life Spine, 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。
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相关器械（代码：OVE）
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。
K263049SABER-C SystemElevation SpineK261882Pisces-SC Standalone Cervical Interbody SystemOsseus Fusions Systems, LLCK261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.
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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