FDA 510(k)

PRODENSE Bone Graft Substitute

K-Number: K182823 · 2018-11-02

Decision Date2018-11-02

Product CodeMQV

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PRODENSE Bone Graft Substitute is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2018-11-02 under 510(k) number K182823. 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 PRODENSE Bone Graft Substitute?

PRODENSE Bone Graft Substitute is a medical device that received FDA 510(k) clearance on 2018-11-02. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K182823.

When did PRODENSE Bone Graft Substitute receive FDA 510(k) clearance?

PRODENSE Bone Graft Substitute received FDA 510(k) clearance on 2018-11-02, under 510(k) number K182823.

Who is the listed applicant for PRODENSE Bone Graft Substitute?

The FDA 510(k) record lists Wrightmedicaltechnologyinc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRODENSE Bone Graft Substitute?

The FDA product code for PRODENSE Bone Graft Substitute is MQV.

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Related Devices (Code: MQV)

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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.