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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 a medical device manufactured by Novabone Products, LLC. It received FDA 510(k) clearance on 2017-01-18 under approval 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. It is manufactured by Novabone Products, LLC. The 510(k) number is K163310.

When was NovaBone IRM approved by the FDA?

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

What company makes NovaBone IRM?

NovaBone IRM is manufactured by Novabone Products, LLC.

What is the FDA product code for NovaBone IRM?

The FDA product code for NovaBone IRM is MQV.

Other Devices by Novabone Products, LLC

K220498NovoGen Wound Matrix K242299NovaBone Putty - Synthetic Bioactive Bone Graft K240404NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615)

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K161447HydroSet XTOrthovita, Inc. K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp.

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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