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FDA 510(k)

Avitus® DragonWing Large Volume Autograft Delivery System

K-Number: K231456 · 2023-07-17

ApplicantAvitus Orthopaedics, Inc.
Decision Date2023-07-17
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Avitus® DragonWing Large Volume Autograft Delivery System is a medical device manufactured by Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-07-17 under approval number K231456. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avitus® DragonWing Large Volume Autograft Delivery System?

Avitus® DragonWing Large Volume Autograft Delivery System is a medical device that received FDA 510(k) clearance on 2023-07-17. It is manufactured by Avitus Orthopaedics, Inc.. The 510(k) number is K231456.

When was Avitus® DragonWing Large Volume Autograft Delivery System approved by the FDA?

Avitus® DragonWing Large Volume Autograft Delivery System received FDA 510(k) clearance on 2023-07-17, under approval number K231456.

What company makes Avitus® DragonWing Large Volume Autograft Delivery System?

Avitus® DragonWing Large Volume Autograft Delivery System is manufactured by Avitus Orthopaedics, Inc..

What is the FDA product code for Avitus® DragonWing Large Volume Autograft Delivery System?

The FDA product code for Avitus® DragonWing Large Volume Autograft Delivery System is FMF.

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Other Devices by Avitus Orthopaedics, Inc.

K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm K210631Avitus(r) Bone Harvester K230492Avitus® Precision Autograft Delivery System

Related Devices (Code: FMF)

K162180Disposable Insulin SyringeBerpu Medical Technology Co., Ltd. K162081BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin SyringeBecton, Dickinson and Company K162602NovoPen EchoNovo Nordisk, Inc. K161568Bone Solutions Mixing and Delivery SystemBone Solutions, Inc. K152879Sure-Fine Insulin SyringesShina Med Corporation K160629InPenCompanion Medical, 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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