The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Galaxy Unyco System.
| Device ID | K153233 |
| 510k Number | K153233 |
| 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 | 2015-11-09 |
| Decision Date | 2016-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242513667 | K153233 | 000 |
| 18054242513650 | K153233 | 000 |
| 18054242513643 | K153233 | 000 |
| 18054242513636 | K153233 | 000 |
| 18054242513629 | K153233 | 000 |
| 18054242513612 | K153233 | 000 |
| 18054242513605 | K153233 | 000 |