The following data is part of a premarket notification filed by Orthofix Srl with the FDA for G-beam Fusion Beaming System.
| Device ID | K172698 |
| 510k Number | K172698 |
| Device Name: | G-Beam Fusion Beaming System |
| Classification | Screw, Fixation, Bone |
| Applicant | Orthofix Srl Bussolengo, IT 37012 |
| Contact | Gianluca Ricadona |
| Correspondent | Gianluca Ricadona Wagoner Consulting LLC Via Delle Nazioni, 9 37012 Bussolengo, IT |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-07 |
| Decision Date | 2018-02-07 |
| Summary: | summary |