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FDA 510(k)

VK100 Percutaneous Vertebral Augmentation System

K-Number: K192403 · 2019-11-08

ApplicantBonwrx, Ltd.
Decision Date2019-11-08
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VK100 Percutaneous Vertebral Augmentation System is the device name listed in this FDA 510(k) record. The listed applicant is Bonwrx, Ltd.. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K192403. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VK100 Percutaneous Vertebral Augmentation System?

VK100 Percutaneous Vertebral Augmentation System is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Bonwrx, Ltd.. The 510(k) number is K192403.

When did VK100 Percutaneous Vertebral Augmentation System receive FDA 510(k) clearance?

VK100 Percutaneous Vertebral Augmentation System received FDA 510(k) clearance on 2019-11-08, under 510(k) number K192403.

Who is the listed applicant for VK100 Percutaneous Vertebral Augmentation System?

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

What is the FDA product code for VK100 Percutaneous Vertebral Augmentation System?

The FDA product code for VK100 Percutaneous Vertebral Augmentation System is NDN.

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Official Source

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