O-Genesis Graft Delivery System

Syringe, Piston

Orthofix, Inc.

The following data is part of a premarket notification filed by Orthofix, Inc. with the FDA for O-genesis Graft Delivery System.

Pre-market Notification Details

Device IDK200606
510k NumberK200606
Device Name:O-Genesis Graft Delivery System
ClassificationSyringe, Piston
Applicant Orthofix, Inc. 3451 Plano Parkway Lewisville,  TX  75056
ContactTroy Brooks
CorrespondentTroy Brooks
Orthofix, Inc. 3451 Plano Parkway Lewisville,  TX  75056
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-05-01

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