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FDA 510(k)

BrackFix

K-Number: K183147 · 2019-03-01

ApplicantVoco GmbH
Decision Date2019-03-01
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BrackFix is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2019-03-01 under approval number K183147. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BrackFix?

BrackFix is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Voco GmbH. The 510(k) number is K183147.

When was BrackFix approved by the FDA?

BrackFix received FDA 510(k) clearance on 2019-03-01, under approval number K183147.

What company makes BrackFix?

BrackFix is manufactured by Voco GmbH.

What is the FDA product code for BrackFix?

The FDA product code for BrackFix is DYH.

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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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