The following data is part of a premarket notification filed by Satelec - Acteon Group with the FDA for Piezotome Cube.
| Device ID | K172137 |
| 510k Number | K172137 |
| Device Name: | PIEZOTOME CUBE |
| Classification | Drill, Bone, Powered |
| Applicant | Satelec - Acteon Group 17 Avenue Gustave Eiffel Merignac, FR 33708 |
| Contact | Philippe Girard |
| Correspondent | Argie Zoubroulis Satelec - Acteon Group 124 Gaither Drive Suite # 140 Mt. Laurel, NJ 08054 |
| Product Code | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-17 |
| Decision Date | 2018-05-03 |
| Summary: | summary |