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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 the device name listed in this FDA 510(k) record. The listed applicant is Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-06-26 under 510(k) 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. The listed applicant is Avitus Orthopaedics, Inc.. The 510(k) number is K230492.

When did Avitus® Precision Autograft Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for Avitus® Precision Autograft Delivery System?

The FDA 510(k) record lists Avitus Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Avitus Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231456Avitus® DragonWing Large Volume Autograft Delivery SystemK210631Avitus(r) Bone HarvesterK170539Avitus 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

Related Devices (Code: FMF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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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