FDA 510(k)

ROSA Bracket

K-Number: K182672 · 2019-11-15

Decision Date2019-11-15

Product CodeNJM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ROSA Bracket is the device name listed in this FDA 510(k) record. The listed applicant is Gni Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under 510(k) 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. The listed applicant is Gni Co., Ltd.. The 510(k) number is K182672.

When did ROSA Bracket receive FDA 510(k) clearance?

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

Who is the listed applicant for ROSA Bracket?

The FDA 510(k) record lists Gni Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROSA Bracket?

The FDA product code for ROSA Bracket is NJM.

Other records listing Gni Co., Ltd. as applicant

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.

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

Related Devices (Code: NJM)

K232827LightForce Orthodontic SystemLightforce Orthodontics K232011CleoAmerican Orthodontics K231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna Flex K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos K222764LightForce Orthodontic SystemLightforce Orthodontics

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.