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FDA 510(k)

MCS Bone Graft

K-Number: K162860 · 2017-02-13

ApplicantBioventus, LLC
Decision Date2017-02-13
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MCS Bone Graft is a medical device manufactured by Bioventus, LLC. It received FDA 510(k) clearance on 2017-02-13 under approval number K162860. 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 MCS Bone Graft?

MCS Bone Graft is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Bioventus, LLC. The 510(k) number is K162860.

When was MCS Bone Graft approved by the FDA?

MCS Bone Graft received FDA 510(k) clearance on 2017-02-13, under approval number K162860.

What company makes MCS Bone Graft?

MCS Bone Graft is manufactured by Bioventus, LLC.

What is the FDA product code for MCS Bone Graft?

The FDA product code for MCS Bone Graft is MQV.

Other Devices by Bioventus, LLC

K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE Putty K233368Allograft Delivery Device (OFAC-C) K243782StimTrial Neuromodulation System K243678TalisMann Neuromodulation System PMA P900009Stimulator, bone growth, non-invasive PMA P170007Acid, hyaluronic, intraarticular

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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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