FDA 510(k)

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

Número K: K162062 · 2016-11-01

Data da decisão2016-11-01

Código do produtoHRX

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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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