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FDA 510(k)

EzOrtho

K-Number: K211793 · 2021-08-23

ApplicantEwoosoft Co., Ltd.
Decision Date2021-08-23
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EzOrtho is a medical device manufactured by Ewoosoft Co., Ltd.. It received FDA 510(k) clearance on 2021-08-23 under approval number K211793. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EzOrtho?

EzOrtho is a medical device that received FDA 510(k) clearance on 2021-08-23. It is manufactured by Ewoosoft Co., Ltd.. The 510(k) number is K211793.

When was EzOrtho approved by the FDA?

EzOrtho received FDA 510(k) clearance on 2021-08-23, under approval number K211793.

What company makes EzOrtho?

EzOrtho is manufactured by Ewoosoft Co., Ltd..

What is the FDA product code for EzOrtho?

The FDA product code for EzOrtho is LLZ.

Other Devices by Ewoosoft Co., Ltd.

K163539Ez3D-i / E3 K161246Ez3D-i / E3 K161117EzDent-i / E2 / Prora View K152746Ez3D Plus K173094OrthoVision K172364EzDent-i / E2 / Prora View

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

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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