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FDA 510(k)

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon

K-Number: K162062 · 2016-11-01

ApplicantStryker Corporation
Decision Date2016-11-01
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Stryker Corporation. The 510(k) number is K162062.

When was AVAmax Vertebral Balloon, AVAflex Vertebral Balloon approved by the FDA?

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

What company makes AVAmax Vertebral Balloon, AVAflex Vertebral Balloon?

AVAmax Vertebral Balloon, AVAflex Vertebral Balloon is manufactured by Stryker Corporation.

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.

Related Clinical Trials

NCT07408726 Monoaxial vs. Polyaxial Percutaneous Hybrid Stabilization NOT_YET_RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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