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FDA 510(k)

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE

K-Number: K080220 · 2008-07-28

ApplicantItalia Medica S.R.L.
Decision Date2008-07-28
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Italia Medica S.R.L.. It received FDA 510(k) clearance on 2008-07-28 under 510(k) number K080220. 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 PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE?

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE is a medical device that received FDA 510(k) clearance on 2008-07-28. The listed applicant is Italia Medica S.R.L.. The 510(k) number is K080220.

When did PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE receive FDA 510(k) clearance?

PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE received FDA 510(k) clearance on 2008-07-28, under 510(k) number K080220.

Who is the listed applicant for PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE?

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

What is the FDA product code for PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE?

The FDA product code for PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE is DZI.

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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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