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FDA 510(k)

IGNITE Bone Void Filler

K-Number: K190482 · 2019-05-28

ApplicantWrightmedicaltechnologyinc
Decision Date2019-05-28
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

IGNITE Bone Void Filler is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2019-05-28 under 510(k) number K190482. 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 IGNITE Bone Void Filler?

IGNITE Bone Void Filler is a medical device that received FDA 510(k) clearance on 2019-05-28. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K190482.

When did IGNITE Bone Void Filler receive FDA 510(k) clearance?

IGNITE Bone Void Filler received FDA 510(k) clearance on 2019-05-28, under 510(k) number K190482.

Who is the listed applicant for IGNITE Bone Void Filler?

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 IGNITE Bone Void Filler?

The FDA product code for IGNITE Bone Void Filler 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.

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