The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Galaxy Unyco System.
| Device ID | K170146 |
| 510k Number | K170146 |
| Device Name: | Galaxy UNYCO System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Orthofix Srl Via Delle Nazioni 9 Bussolengo, IT 37012 |
| Contact | Gianluca Ricadona |
| Correspondent | Cheryl Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, NC 28408 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-17 |
| Decision Date | 2017-10-12 |
| Summary: | summary |