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FDA 510(k)

PIEZOSURGERY FLEX

K-Number: K132848 · 2013-11-29

ApplicantMectron S.P.A.
Decision Date2013-11-29
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY FLEX 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 2013-11-29 under 510(k) number K132848. 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 FLEX?

PIEZOSURGERY FLEX is a medical device that received FDA 510(k) clearance on 2013-11-29. The listed applicant is Mectron S.P.A.. The 510(k) number is K132848.

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

PIEZOSURGERY FLEX received FDA 510(k) clearance on 2013-11-29, under 510(k) number K132848.

Who is the listed applicant for PIEZOSURGERY FLEX?

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 FLEX?

The FDA product code for PIEZOSURGERY FLEX is JDX.

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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 touchK242432MT-BoneK231391Combi TouchK171326Piezosurgery WhiteK171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEK153743PIEZOSURGERY PLUS

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Related Devices (Code: JDX)

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.

K201274Ultrasonic Osteotomy Surgical SystemSmtp Technology Co., Ltd.K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research ConsortiumK163610PIEZOTOME M+, PIEZOTOME M+ HandpieceSatalec-Acteon GroupK153743PIEZOSURGERY PLUSMectron S.P.A.K100410PIEZOELECTRIC SYSTEMSatelecK093805OSCAR 3Orthosonics, 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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