The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Galaxy Unyco Diaphyseal Tibia Kit.
| Device ID | K142052 |
| 510k Number | K142052 |
| Device Name: | ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | ORTHOFIX SRL PO BOX 15729 Wilmington, NC 28408 |
| Contact | Cheryl Wagoner |
| Correspondent | Cheryl Wagoner ORTHOFIX SRL 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 | 2014-07-28 |
| Decision Date | 2014-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242515180 | K142052 | 000 |
| 18054242515173 | K142052 | 000 |
| 18054242515166 | K142052 | 000 |
| 18054242515159 | K142052 | 000 |
| 18054242512325 | K142052 | 000 |
| 18054242512318 | K142052 | 000 |
| 18054242512301 | K142052 | 000 |
| 18054242512295 | K142052 | 000 |