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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 the device name listed in this FDA 510(k) record. The listed applicant is Rex Implants, Inc.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) 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. The listed applicant is Rex Implants, Inc.. The 510(k) number is K211872.

When did PiezoImplant System receive FDA 510(k) clearance?

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

Who is the listed applicant for PiezoImplant System?

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

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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