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FDA 510(k)

Tactoset® Injectable Bone Substitute

K-Number: K231968 · 2023-12-20

Decision Date2023-12-20
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Tactoset® Injectable Bone Substitute is a medical device manufactured by Anika Therapeutics, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K231968. 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 Tactoset® Injectable Bone Substitute?

Tactoset® Injectable Bone Substitute is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Anika Therapeutics, Inc.. The 510(k) number is K231968.

When was Tactoset® Injectable Bone Substitute approved by the FDA?

Tactoset® Injectable Bone Substitute received FDA 510(k) clearance on 2023-12-20, under approval number K231968.

What company makes Tactoset® Injectable Bone Substitute?

Tactoset® Injectable Bone Substitute is manufactured by Anika Therapeutics, Inc..

What is the FDA product code for Tactoset® Injectable Bone Substitute?

The FDA product code for Tactoset® Injectable Bone Substitute is MQV.

Other Devices by Anika Therapeutics, Inc.

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Related Devices (Code: MQV)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.