Cascadia Interbody System
K号: K162264 · 2016-09-21
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器械摘要
Cascadia Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K162264. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Cascadia Interbody System?
Cascadia Interbody System is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is K2m, Inc.. The 510(k) number is K162264.
When did Cascadia Interbody System receive FDA 510(k) clearance?
Cascadia Interbody System received FDA 510(k) clearance on 2016-09-21, under 510(k) number K162264.
Who is the listed applicant for Cascadia Interbody System?
The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Cascadia Interbody System?
The FDA product code for Cascadia Interbody System is MAX.
相关临床试验
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列明K2m, 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。
相关器械（代码：MAX）
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。
K261049SCALA® TLSpineart SAK261430TruLift Expandable SystemLife Spine, Inc.K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc.K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc.K253420Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody SySeaSpine Orthopedics CorporationK253151Fule Interbody Fusion Cage SystemBeijing Fule Science & Technology Development 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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