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FDA 510(k)

VENUS Bracket, ROSE Bracket

K-Number: K201410 · 2021-03-12

ApplicantGni Co., Ltd.
Decision Date2021-03-12
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VENUS Bracket, ROSE Bracket is a medical device manufactured by Gni Co., Ltd.. It received FDA 510(k) clearance on 2021-03-12 under approval number K201410. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VENUS Bracket, ROSE Bracket?

VENUS Bracket, ROSE Bracket is a medical device that received FDA 510(k) clearance on 2021-03-12. It is manufactured by Gni Co., Ltd.. The 510(k) number is K201410.

When was VENUS Bracket, ROSE Bracket approved by the FDA?

VENUS Bracket, ROSE Bracket received FDA 510(k) clearance on 2021-03-12, under approval number K201410.

What company makes VENUS Bracket, ROSE Bracket?

VENUS Bracket, ROSE Bracket is manufactured by Gni Co., Ltd..

What is the FDA product code for VENUS Bracket, ROSE Bracket?

The FDA product code for VENUS Bracket, ROSE Bracket is NJM.

Other Devices by Gni Co., Ltd.

K182672ROSA Bracket K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew]

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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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