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FDA 510(k)

PIEZOSURGERY MEDICAL

K-Number: K083284 · 2009-04-08

ApplicantPiezosurgery S.R.L.
Decision Date2009-04-08
Product CodeJDX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY MEDICAL is the device name listed in this FDA 510(k) record. The listed applicant is Piezosurgery S.R.L.. It received FDA 510(k) clearance on 2009-04-08 under 510(k) number K083284. 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 MEDICAL?

PIEZOSURGERY MEDICAL is a medical device that received FDA 510(k) clearance on 2009-04-08. The listed applicant is Piezosurgery S.R.L.. The 510(k) number is K083284.

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

PIEZOSURGERY MEDICAL received FDA 510(k) clearance on 2009-04-08, under 510(k) number K083284.

Who is the listed applicant for PIEZOSURGERY MEDICAL?

The FDA 510(k) record lists Piezosurgery S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PIEZOSURGERY MEDICAL?

The FDA product code for PIEZOSURGERY MEDICAL is JDX.

Related Clinical Trials

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Other records listing Piezosurgery S.R.L. 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.

K091227PIEZOSURGERY 3; OSSTEM PIEZOK052518PIEZOSURGERYK043408PIEZOSURGERY DEVICE

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.K132848PIEZOSURGERY FLEXMectron S.P.A.K100410PIEZOELECTRIC SYSTEMSatelec

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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