OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft
K-Number: K200064 · 2020-08-14
ApplicantSurGenTec, LLC
Decision Date2020-08-14
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2020-08-14 under approval number K200064. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by SurGenTec, LLC. The 510(k) number is K200064.
When was OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft approved by the FDA?
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft received FDA 510(k) clearance on 2020-08-14, under approval number K200064.
What company makes OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?
OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is manufactured by SurGenTec, LLC.
What is the FDA product code for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft?
The FDA product code for OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft is MQV.
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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.