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FDA 510(k)

PIEZOSURGERY 3; OSSTEM PIEZO

K-Number: K091227 · 2009-12-29

ApplicantPiezosurgery S.R.L.
Decision Date2009-12-29
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZOSURGERY 3; OSSTEM PIEZO 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 2009-12-29 under 510(k) number K091227. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIEZOSURGERY 3; OSSTEM PIEZO?

PIEZOSURGERY 3; OSSTEM PIEZO is a medical device that received FDA 510(k) clearance on 2009-12-29. The listed applicant is Piezosurgery S.R.L.. The 510(k) number is K091227.

When did PIEZOSURGERY 3; OSSTEM PIEZO receive FDA 510(k) clearance?

PIEZOSURGERY 3; OSSTEM PIEZO received FDA 510(k) clearance on 2009-12-29, under 510(k) number K091227.

Who is the listed applicant for PIEZOSURGERY 3; OSSTEM PIEZO?

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 3; OSSTEM PIEZO?

The FDA product code for PIEZOSURGERY 3; OSSTEM PIEZO is DZI.

Related Clinical Trials

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.

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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.

K083284PIEZOSURGERY MEDICALK052518PIEZOSURGERYK043408PIEZOSURGERY DEVICE

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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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