The following data is part of a premarket notification filed by Sign Fracture Care International with the FDA for Sign Pediatric Fin Nail.
| Device ID | K122823 |
| 510k Number | K122823 |
| Device Name: | SIGN PEDIATRIC FIN NAIL |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | SIGN FRACTURE CARE INTERNATIONAL 451 Hills St Ste B Richland, WA 99354 |
| Contact | Douglas Donnelly |
| Correspondent | Douglas Donnelly SIGN FRACTURE CARE INTERNATIONAL 451 Hills St Ste 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 | 2012-09-14 |
| Decision Date | 2013-04-16 |
| Summary: | summary |