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FDA 510(k)

PIEZOSURGERY PLUS

K-Number: K153743 · 2016-05-25

ApplicantMectron S.P.A.
Decision Date2016-05-25
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY PLUS is a medical device manufactured by Mectron S.P.A.. It received FDA 510(k) clearance on 2016-05-25 under approval number K153743. The device is classified under product code JDX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOSURGERY PLUS?

PIEZOSURGERY PLUS is a medical device that received FDA 510(k) clearance on 2016-05-25. It is manufactured by Mectron S.P.A.. The 510(k) number is K153743.

When was PIEZOSURGERY PLUS approved by the FDA?

PIEZOSURGERY PLUS received FDA 510(k) clearance on 2016-05-25, under approval number K153743.

What company makes PIEZOSURGERY PLUS?

PIEZOSURGERY PLUS is manufactured by Mectron S.P.A..

What is the FDA product code for PIEZOSURGERY PLUS?

The FDA product code for PIEZOSURGERY PLUS is JDX.

Other Devices by Mectron S.P.A.

K171326Piezosurgery White K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE K231391Combi Touch K242432MT-Bone K251425turbodent touch

Related Devices (Code: JDX)

K163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon Group K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.

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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