The following data is part of a premarket notification filed by Piezosurgery S.r.l. with the FDA for Piezosurgery 3; Osstem Piezo.
| Device ID | K091227 |
| 510k Number | K091227 |
| Device Name: | PIEZOSURGERY 3; OSSTEM PIEZO |
| Classification | Drill, Bone, Powered |
| Applicant | PIEZOSURGERY S.R.L. VIA ALDO MORO 20 Brescia, IT 25124 |
| Contact | Ing. Enrico Perfler |
| Correspondent | Ing. Enrico Perfler PIEZOSURGERY S.R.L. VIA ALDO MORO 20 Brescia, IT 25124 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-28 |
| Decision Date | 2009-12-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322031200231010 | K091227 | 000 |