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FDA 510(k)

HydroSet XT

K-Number: K161447 · 2016-10-06

ApplicantOrthovita, Inc.
Decision Date2016-10-06
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HydroSet XT is a medical device manufactured by Orthovita, Inc.. It received FDA 510(k) clearance on 2016-10-06 under approval number K161447. 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 HydroSet XT?

HydroSet XT is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Orthovita, Inc.. The 510(k) number is K161447.

When was HydroSet XT approved by the FDA?

HydroSet XT received FDA 510(k) clearance on 2016-10-06, under approval number K161447.

What company makes HydroSet XT?

HydroSet XT is manufactured by Orthovita, Inc..

What is the FDA product code for HydroSet XT?

The FDA product code for HydroSet XT is MQV.

Other Devices by Orthovita, Inc.

K153608Vitoss BiModal Bone Graft Substitute Foam Strip K163621Vitoss Bioactive (BA) Injectable

Related Devices (Code: MQV)

K160566Cerasorb Ortho FoamCurasan AG K160446MCP Bone PuttyBiostructures, LLC K161351NanoBone SBX PuttyArtoss GmbH K152077MaxiGenHans Biomed Corp. K151271BellaFuseHans Biomed Corp. K153608Vitoss BiModal Bone Graft Substitute Foam StripOrthovita, Inc.

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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