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FDA 510(k)

PRO-DENSE BONE GRAFT SUBSTITUTE

K-Number: K113871 · 2013-03-25

ApplicantWrightmedicaltechnologyinc
Decision Date2013-03-25
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRO-DENSE 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 2013-03-25 under 510(k) number K113871. 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 PRO-DENSE BONE GRAFT SUBSTITUTE?

PRO-DENSE BONE GRAFT SUBSTITUTE is a medical device that received FDA 510(k) clearance on 2013-03-25. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K113871.

When did PRO-DENSE BONE GRAFT SUBSTITUTE receive FDA 510(k) clearance?

PRO-DENSE BONE GRAFT SUBSTITUTE received FDA 510(k) clearance on 2013-03-25, under 510(k) number K113871.

Who is the listed applicant for PRO-DENSE 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 PRO-DENSE BONE GRAFT SUBSTITUTE?

The FDA product code for PRO-DENSE BONE GRAFT SUBSTITUTE 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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