K2M Growing Spine System
K号: K161028 · 2016-07-22
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器械摘要
K2M Growing Spine 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 2016-07-22 under 510(k) number K161028. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the K2M Growing Spine System?
K2M Growing Spine System is a medical device that received FDA 510(k) clearance on 2016-07-22. The listed applicant is K2m, Inc.. The 510(k) number is K161028.
When did K2M Growing Spine System receive FDA 510(k) clearance?
K2M Growing Spine System received FDA 510(k) clearance on 2016-07-22, under 510(k) number K161028.
Who is the listed applicant for K2M Growing Spine 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 K2M Growing Spine System?
The FDA product code for K2M Growing Spine System is PGM.
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：PGM）
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。
K251961SDS Growing RodBAAT Medical Products B.V.K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.K213196MARVEL™ Growing RodsGlobus Medical, Inc.K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics CorporationK191212CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine SystemMedos International SARLK181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, 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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