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FDA 510(k)

URIS OMNI Narrow System & Prosthetic

K-Number: K200817 · 2020-10-07

ApplicantTruabutment, Inc.
Decision Date2020-10-07
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

URIS OMNI Narrow System & Prosthetic is a medical device manufactured by Truabutment, Inc.. It received FDA 510(k) clearance on 2020-10-07 under approval number K200817. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URIS OMNI Narrow System & Prosthetic?

URIS OMNI Narrow System & Prosthetic is a medical device that received FDA 510(k) clearance on 2020-10-07. It is manufactured by Truabutment, Inc.. The 510(k) number is K200817.

When was URIS OMNI Narrow System & Prosthetic approved by the FDA?

URIS OMNI Narrow System & Prosthetic received FDA 510(k) clearance on 2020-10-07, under approval number K200817.

What company makes URIS OMNI Narrow System & Prosthetic?

URIS OMNI Narrow System & Prosthetic is manufactured by Truabutment, Inc..

What is the FDA product code for URIS OMNI Narrow System & Prosthetic?

The FDA product code for URIS OMNI Narrow System & Prosthetic is DZE.

Related Clinical Trials

NCT07204925 Towards Efficient Personalization of Computerized Lower Limb Prostheses Via Reinforcement Learning in a Clinical Setup - Group 1 RECRUITING NCT04358601 All-poly Versus Metal-backed ACTIVE_NOT_RECRUITING NCT05124652 An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation RECRUITING NCT07560891 LBBAP vs. CS Pacing for CRT in Permanent Atrial Fibrillation and Heart Failure (SYNC-AF) NOT_YET_RECRUITING NCT03432325 Neural Enabled Prosthesis for Upper Limb Amputees ACTIVE_NOT_RECRUITING NCT05467163 Conduction System Pacing Versus Biventricular Pacing After Atrioventricular Node Ablation ACTIVE_NOT_RECRUITING

Other Devices by Truabutment, Inc.

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Related Devices (Code: DZE)

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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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