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FDA 510(k)

NovoGro

K-Number: K162087 · 2017-04-18

ApplicantOsteonovus, Inc.
Decision Date2017-04-18
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NovoGro is the device name listed in this FDA 510(k) record. The listed applicant is Osteonovus, Inc.. It received FDA 510(k) clearance on 2017-04-18 under 510(k) number K162087. 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 NovoGro?

NovoGro is a medical device that received FDA 510(k) clearance on 2017-04-18. The listed applicant is Osteonovus, Inc.. The 510(k) number is K162087.

When did NovoGro receive FDA 510(k) clearance?

NovoGro received FDA 510(k) clearance on 2017-04-18, under 510(k) number K162087.

Who is the listed applicant for NovoGro?

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

What is the FDA product code for NovoGro?

The FDA product code for NovoGro is MQV.

Other records listing Osteonovus, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173525NovoGro

Related Devices (Code: MQV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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