Piezosurgery 3; Osstem Piezo
FDA 510(k) K091227 · Piezosurgery S.R.L.
510(k) numberK091227
Submission
- Device name
- Piezosurgery 3; Osstem Piezo
- Applicant
- Piezosurgery S.R.L.
Brescia, IT - Received
- April 28, 2009
- Decision date
- December 29, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Piezosurgery 3; Osstem Piezo cleared by the FDA?
Piezosurgery 3; Osstem Piezo (K091227) received a 510(k) decision of Substantially Equivalent on December 29, 2009, 245 days after the submission was received.
What is the product code of K091227?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.