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FDA 510(k)

O-Genesis Graft Delivery System

K-Number: K200606 · 2020-05-01

ApplicantOrthofix, Inc.
Decision Date2020-05-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

O-Genesis Graft Delivery System is a medical device manufactured by Orthofix, Inc.. It received FDA 510(k) clearance on 2020-05-01 under approval number K200606. 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 O-Genesis Graft Delivery System?

O-Genesis Graft Delivery System is a medical device that received FDA 510(k) clearance on 2020-05-01. It is manufactured by Orthofix, Inc.. The 510(k) number is K200606.

When was O-Genesis Graft Delivery System approved by the FDA?

O-Genesis Graft Delivery System received FDA 510(k) clearance on 2020-05-01, under approval number K200606.

What company makes O-Genesis Graft Delivery System?

O-Genesis Graft Delivery System is manufactured by Orthofix, Inc..

What is the FDA product code for O-Genesis Graft Delivery System?

The FDA product code for O-Genesis Graft Delivery System is FMF.

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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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