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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 the device name listed in this FDA 510(k) record. The listed applicant is Orthovita, Inc.. It received FDA 510(k) clearance on 2016-10-06 under 510(k) 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. The listed applicant is Orthovita, Inc.. The 510(k) number is K161447.

When did HydroSet XT receive FDA 510(k) clearance?

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

Who is the listed applicant for HydroSet XT?

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

What is the FDA product code for HydroSet XT?

The FDA product code for HydroSet XT is MQV.

Other records listing Orthovita, Inc. as applicant

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Related Devices (Code: MQV)

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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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