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FDA 510(k)

Mini and Micro Fragments Reconstruction System – GMReis

K-Number: K182718 · 2019-12-23

ApplicantGm Dos Reis Industria E Comerico Ltda.
Decision Date2019-12-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Mini and Micro Fragments Reconstruction System – GMReis is a medical device manufactured by Gm Dos Reis Industria E Comerico Ltda.. It received FDA 510(k) clearance on 2019-12-23 under approval number K182718. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Mini and Micro Fragments Reconstruction System – GMReis?

Mini and Micro Fragments Reconstruction System – GMReis is a medical device that received FDA 510(k) clearance on 2019-12-23. It is manufactured by Gm Dos Reis Industria E Comerico Ltda.. The 510(k) number is K182718.

When was Mini and Micro Fragments Reconstruction System – GMReis approved by the FDA?

Mini and Micro Fragments Reconstruction System – GMReis received FDA 510(k) clearance on 2019-12-23, under approval number K182718.

What company makes Mini and Micro Fragments Reconstruction System – GMReis?

Mini and Micro Fragments Reconstruction System – GMReis is manufactured by Gm Dos Reis Industria E Comerico Ltda..

What is the FDA product code for Mini and Micro Fragments Reconstruction System – GMReis?

The FDA product code for Mini and Micro Fragments Reconstruction System – GMReis is HRS.

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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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