FDA 510(k)

The BioBrace Implant

K-Number: K203267 · 2021-04-30

Decision Date2021-04-30

Product CodeOWW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

The BioBrace Implant is a medical device manufactured by Biorez, Inc.. It received FDA 510(k) clearance on 2021-04-30 under approval number K203267. The device is classified under product code OWW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the The BioBrace Implant?

The BioBrace Implant is a medical device that received FDA 510(k) clearance on 2021-04-30. It is manufactured by Biorez, Inc.. The 510(k) number is K203267.

When was The BioBrace Implant approved by the FDA?

The BioBrace Implant received FDA 510(k) clearance on 2021-04-30, under approval number K203267.

What company makes The BioBrace Implant?

The BioBrace Implant is manufactured by Biorez, Inc..

What is the FDA product code for The BioBrace Implant?

The FDA product code for The BioBrace Implant is OWW.

Related Clinical Trials

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Official Source

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