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 |