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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 the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2019-03-01 under 510(k) 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. The listed applicant is Voco GmbH. The 510(k) number is K183147.

When did BrackFix receive FDA 510(k) clearance?

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

Who is the listed applicant for BrackFix?

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

What is the FDA product code for BrackFix?

The FDA product code for BrackFix is DYH.

Other records listing Voco GmbH as applicant

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Related Devices (Code: DYH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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