AERO MIS ǽ
K号: K243865 · 2025-03-24
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器械摘要
AERO MIS Facet Fusion System is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Spine. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243865. The device is classified under product code MRW. FDA Decision: Substantially Equivalent.
常见问题
What is the AERO MIS Facet Fusion System?
AERO MIS Facet Fusion System is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Aurora Spine. The 510(k) number is K243865.
When did AERO MIS Facet Fusion System receive FDA 510(k) clearance?
AERO MIS Facet Fusion System received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243865.
Who is the listed applicant for AERO MIS Facet Fusion System?
The FDA 510(k) record lists Aurora Spine as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AERO MIS Facet Fusion System?
The FDA product code for AERO MIS Facet Fusion System is MRW.
相关临床试验
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相关器械（代码：MRW）
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。
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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