The following data is part of a premarket notification filed by Safewire, Llc with the FDA for Y Wire 2.
| Device ID | K140576 |
| 510k Number | K140576 |
| Device Name: | Y WIRE 2 |
| Classification | Passer, Wire, Orthopedic |
| Applicant | SAFEWIRE, LLC 520 BUTTERNUT DR, #8 PMB#256 Holland, MI 49424 |
| Contact | Stephen W Inglese |
| Correspondent | Stephen W Inglese SAFEWIRE, LLC 520 BUTTERNUT DR, #8 PMB#256 Holland, MI 49424 |
| Product Code | HXI |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2014-05-20 |
| Summary: | summary |