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FDA 510(k)

PiezoImplant System

K-Number: K211872 · 2022-10-12

ApplicantRex Implants, Inc.
Decision Date2022-10-12
Product CodeNRQ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PiezoImplant System is a medical device manufactured by Rex Implants, Inc.. It received FDA 510(k) clearance on 2022-10-12 under approval number K211872. The device is classified under product code NRQ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PiezoImplant System?

PiezoImplant System is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Rex Implants, Inc.. The 510(k) number is K211872.

When was PiezoImplant System approved by the FDA?

PiezoImplant System received FDA 510(k) clearance on 2022-10-12, under approval number K211872.

What company makes PiezoImplant System?

PiezoImplant System is manufactured by Rex Implants, Inc..

What is the FDA product code for PiezoImplant System?

The FDA product code for PiezoImplant System is NRQ.

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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