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FDA 510(k)

Orthodontic Fixation Screw [Smart Anchor Miniscrew]

K-Number: K191041 · 2020-08-28

ApplicantGni Co., Ltd.
Decision Date2020-08-28
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is a medical device manufactured by Gni Co., Ltd.. It received FDA 510(k) clearance on 2020-08-28 under approval number K191041. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is a medical device that received FDA 510(k) clearance on 2020-08-28. It is manufactured by Gni Co., Ltd.. The 510(k) number is K191041.

When was Orthodontic Fixation Screw [Smart Anchor Miniscrew] approved by the FDA?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] received FDA 510(k) clearance on 2020-08-28, under approval number K191041.

What company makes Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] is manufactured by Gni Co., Ltd..

What is the FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew]?

The FDA product code for Orthodontic Fixation Screw [Smart Anchor Miniscrew] is OAT.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05639907 Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07362160 Clear Orthodontic Expander Versus Hyrax RECRUITING NCT06024304 InterTAN: Integrated Dual Screw Design Improve Biomechanics/Function Following Fixation Surgery RECRUITING NCT07511296 Orthognathic Surgery With Clear Aligners vs Conventional Brackets COMPLETED

Other Devices by Gni Co., Ltd.

K182672ROSA Bracket K201410VENUS Bracket, ROSE Bracket

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd. K181142Absoanchor MicroimplantDentos, Inc.

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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