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FDA 510(k)

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

K号: K162062 · 2016-11-01

申请人Stryker Corporation
决定日期2016-11-01
产品代码HRX
咨询委员会OR
决定Substantially Equivalent

器械摘要

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2016-11-01 under 510(k) number K162062. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AVAmax Vertebral Balloon, AVAflex Vertebral Balloon?

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon is a medical device that received FDA 510(k) clearance on 2016-11-01. The listed applicant is Stryker Corporation. The 510(k) number is K162062.

When did AVAmax Vertebral Balloon, AVAflex Vertebral Balloon receive FDA 510(k) clearance?

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon received FDA 510(k) clearance on 2016-11-01, under 510(k) number K162062.

Who is the listed applicant for AVAmax Vertebral Balloon, AVAflex Vertebral Balloon?

The FDA 510(k) record lists Stryker Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVAmax Vertebral Balloon, AVAflex Vertebral Balloon?

The FDA product code for AVAmax Vertebral Balloon, AVAflex Vertebral Balloon is HRX.

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列明Stryker Corporation为申报人的其他记录

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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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