Threshold™ Pedicular Fixation System
K号: K161694 · 2016-07-15
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器械摘要
Threshold™ Pedicular Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is Spineology, Inc.. It received FDA 510(k) clearance on 2016-07-15 under 510(k) number K161694. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Threshold™ Pedicular Fixation System?
Threshold™ Pedicular Fixation System is a medical device that received FDA 510(k) clearance on 2016-07-15. The listed applicant is Spineology, Inc.. The 510(k) number is K161694.
When did Threshold™ Pedicular Fixation System receive FDA 510(k) clearance?
Threshold™ Pedicular Fixation System received FDA 510(k) clearance on 2016-07-15, under 510(k) number K161694.
Who is the listed applicant for Threshold™ Pedicular Fixation System?
The FDA 510(k) record lists Spineology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Threshold™ Pedicular Fixation System?
The FDA product code for Threshold™ Pedicular Fixation System is NKB.
相关临床试验
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列明Spineology, 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：NKB）
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。
K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ 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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