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FDA 510(k)

NovaBone IRM

K-Number: K163310 · 2017-01-18

ApplicantNovabone Products, LLC
Decision Date2017-01-18
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NovaBone IRM is the device name listed in this FDA 510(k) record. The listed applicant is Novabone Products, LLC. It received FDA 510(k) clearance on 2017-01-18 under 510(k) number K163310. 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 NovaBone IRM?

NovaBone IRM is a medical device that received FDA 510(k) clearance on 2017-01-18. The listed applicant is Novabone Products, LLC. The 510(k) number is K163310.

When did NovaBone IRM receive FDA 510(k) clearance?

NovaBone IRM received FDA 510(k) clearance on 2017-01-18, under 510(k) number K163310.

Who is the listed applicant for NovaBone IRM?

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

What is the FDA product code for NovaBone IRM?

The FDA product code for NovaBone IRM is MQV.

Other records listing Novabone Products, LLC 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.

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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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