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FDA 510(k)

Vitoss Bioactive (BA) Injectable

K-Number: K163621 · 2017-05-02

ApplicantOrthovita, Inc.
Decision Date2017-05-02
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vitoss Bioactive (BA) Injectable is a medical device manufactured by Orthovita, Inc.. It received FDA 510(k) clearance on 2017-05-02 under approval number K163621. 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 Vitoss Bioactive (BA) Injectable?

Vitoss Bioactive (BA) Injectable is a medical device that received FDA 510(k) clearance on 2017-05-02. It is manufactured by Orthovita, Inc.. The 510(k) number is K163621.

When was Vitoss Bioactive (BA) Injectable approved by the FDA?

Vitoss Bioactive (BA) Injectable received FDA 510(k) clearance on 2017-05-02, under approval number K163621.

What company makes Vitoss Bioactive (BA) Injectable?

Vitoss Bioactive (BA) Injectable is manufactured by Orthovita, Inc..

What is the FDA product code for Vitoss Bioactive (BA) Injectable?

The FDA product code for Vitoss Bioactive (BA) Injectable is MQV.

Other Devices by Orthovita, Inc.

K161447HydroSet XT K153608Vitoss BiModal Bone Graft Substitute Foam Strip

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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