FDA 510(k)

PIEZOSURGERY PLUS

K-Number: K153743 · 2016-05-25

Decision Date2016-05-25

Product CodeJDX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Mectron S.P.A.. It received FDA 510(k) clearance on 2016-05-25 under 510(k) 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. The listed applicant is Mectron S.P.A.. The 510(k) number is K153743.

When did PIEZOSURGERY PLUS receive FDA 510(k) clearance?

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

Who is the listed applicant for PIEZOSURGERY PLUS?

The FDA 510(k) record lists Mectron S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIEZOSURGERY PLUS?

The FDA product code for PIEZOSURGERY PLUS is JDX.

Other records listing Mectron S.P.A. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: JDX)

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

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.