The following data is part of a premarket notification filed by Orthofix Srl with the FDA for Orthofix Mj-flex The New Metaizeau Nail.
| Device ID | K173051 |
| 510k Number | K173051 |
| Device Name: | Orthofix MJ-FLEX THE NEW METAIZEAU NAIL |
| Classification | Pin, Fixation, Smooth |
| Applicant | Orthofix Srl Via Delle Nazioni 9 Bussolengo, IT 37012 |
| Contact | Gianluca Ricadona |
| Correspondent | Chery Wagoner Wagoner Consulting LLC PO Box 15729 Wilmington, NC 24408 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-28 |
| Decision Date | 2017-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18054242518839 | K173051 | 000 |
| 18054242518730 | K173051 | 000 |
| 18054242518747 | K173051 | 000 |
| 18054242518754 | K173051 | 000 |
| 18054242518761 | K173051 | 000 |
| 18054242518778 | K173051 | 000 |
| 18054242518785 | K173051 | 000 |
| 18054242518792 | K173051 | 000 |
| 18054242518808 | K173051 | 000 |
| 18054242518815 | K173051 | 000 |
| 18054242518822 | K173051 | 000 |
| 18054242518723 | K173051 | 000 |