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FDA 510(k)

Avitus® Precision Autograft Delivery System

K-Number: K230492 · 2023-06-26

ApplicantAvitus Orthopaedics, Inc.
Decision Date2023-06-26
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Avitus® Precision Autograft Delivery System is a medical device manufactured by Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-06-26 under approval number K230492. 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® Precision Autograft Delivery System?

Avitus® Precision Autograft Delivery System is a medical device that received FDA 510(k) clearance on 2023-06-26. It is manufactured by Avitus Orthopaedics, Inc.. The 510(k) number is K230492.

When was Avitus® Precision Autograft Delivery System approved by the FDA?

Avitus® Precision Autograft Delivery System received FDA 510(k) clearance on 2023-06-26, under approval number K230492.

What company makes Avitus® Precision Autograft Delivery System?

Avitus® Precision Autograft Delivery System is manufactured by Avitus Orthopaedics, Inc..

What is the FDA product code for Avitus® Precision Autograft Delivery System?

The FDA product code for Avitus® Precision Autograft Delivery System is FMF.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING

Related PubMed Literature

PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026)

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 K231456Avitus® DragonWing Large Volume 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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