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FDA 510(k)

ROSA Bracket

K-Number: K182672 · 2019-11-15

ApplicantGni Co., Ltd.
Decision Date2019-11-15
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROSA Bracket is a medical device manufactured by Gni Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under approval number K182672. 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 ROSA Bracket?

ROSA Bracket is a medical device that received FDA 510(k) clearance on 2019-11-15. It is manufactured by Gni Co., Ltd.. The 510(k) number is K182672.

When was ROSA Bracket approved by the FDA?

ROSA Bracket received FDA 510(k) clearance on 2019-11-15, under approval number K182672.

What company makes ROSA Bracket?

ROSA Bracket is manufactured by Gni Co., Ltd..

What is the FDA product code for ROSA Bracket?

The FDA product code for ROSA Bracket is NJM.

Other Devices by Gni Co., Ltd.

K191041Orthodontic Fixation Screw [Smart Anchor Miniscrew] K201410VENUS Bracket, ROSE Bracket

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America

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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