The following data is part of a premarket notification filed by Flow-fx, Llc with the FDA for Flow-nail.
| Device ID | K221115 |
| 510k Number | K221115 |
| Device Name: | Flow-Nail |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | Flow-FX, LLC 9301 West 191st Street Mokena, IL 60448 |
| Contact | Patrick J. Sweeney |
| Correspondent | Hollace S. Rhodes MCRA,LLC. 803 7th Street NW Washington, DC 20001 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-15 |
| Decision Date | 2022-05-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FLOW-NAIL 85518384 4956100 Live/Registered |
Orthopedic Generations LLC 2012-01-17 |