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FDA 510(k)

Avitus(r) Bone Harvester

K-Number: K210631 · 2021-03-31

ApplicantAvitus Orthopaedics, Inc.
Decision Date2021-03-31
Product CodeKNW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Avitus(r) Bone Harvester is a medical device manufactured by Avitus Orthopaedics, Inc.. It received FDA 510(k) clearance on 2021-03-31 under approval number K210631. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Avitus(r) Bone Harvester?

Avitus(r) Bone Harvester is a medical device that received FDA 510(k) clearance on 2021-03-31. It is manufactured by Avitus Orthopaedics, Inc.. The 510(k) number is K210631.

When was Avitus(r) Bone Harvester approved by the FDA?

Avitus(r) Bone Harvester received FDA 510(k) clearance on 2021-03-31, under approval number K210631.

What company makes Avitus(r) Bone Harvester?

Avitus(r) Bone Harvester is manufactured by Avitus Orthopaedics, Inc..

What is the FDA product code for Avitus(r) Bone Harvester?

The FDA product code for Avitus(r) Bone Harvester is KNW.

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 K231456Avitus® DragonWing Large Volume Autograft Delivery System K230492Avitus® Precision Autograft Delivery System

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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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