Decision Date2020-05-01
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
O-Genesis Graft Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix, Inc.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) 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. The listed applicant is Orthofix, Inc.. The 510(k) number is K200606.
When did O-Genesis Graft Delivery System receive FDA 510(k) clearance?
O-Genesis Graft Delivery System received FDA 510(k) clearance on 2020-05-01, under 510(k) number K200606.
Who is the listed applicant for O-Genesis Graft Delivery System?
The FDA 510(k) record lists Orthofix, Inc. as the applicant. This does not by itself establish the device manufacturer.
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
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