The following data is part of a premarket notification filed by Sign Fracture Care International with the FDA for Sign Im Nail.
| Device ID | K163589 |
| 510k Number | K163589 |
| Device Name: | SIGN IM Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SIGN FRACTURE CARE INTERNATIONAL 451 Hills Street, Suite B Richland, WA 99354 |
| Contact | Robert Schmitt |
| Correspondent | Robert Schmitt SIGN FRACTURE CARE INTERNATIONAL 451 Hills Street, Suite B Richland, WA 99354 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-20 |
| Decision Date | 2017-07-20 |
| Summary: | summary |