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FDA 510(k)

OsteoFlo® HydroPutty™

K-Number: K231716 · 2023-10-02

Decision Date2023-10-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OsteoFlo® HydroPutty™ is a medical device manufactured by SurGenTec, LLC. It received FDA 510(k) clearance on 2023-10-02 under approval number K231716. 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® HydroPutty™?

OsteoFlo® HydroPutty™ is a medical device that received FDA 510(k) clearance on 2023-10-02. It is manufactured by SurGenTec, LLC. The 510(k) number is K231716.

When was OsteoFlo® HydroPutty™ approved by the FDA?

OsteoFlo® HydroPutty™ received FDA 510(k) clearance on 2023-10-02, under approval number K231716.

What company makes OsteoFlo® HydroPutty™?

OsteoFlo® HydroPutty™ is manufactured by SurGenTec, LLC.

What is the FDA product code for OsteoFlo® HydroPutty™?

The FDA product code for OsteoFlo® HydroPutty™ is MQV.

Other Devices by SurGenTec, LLC

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Related Devices (Code: MQV)

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.