Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K210792
Auxein Nailing System · Auxein Medical Private Limited · decided 2021-08-25 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Expert Tibia Nail, Ø8mm x Length 255mm, Titanium, Sterile | TI-520-08-255-S | Auxein Medical Private Limited | HWC | 08903993114377 |
| Expert Tibia Nail, Ø8mm x Length 270mm, Titanium, Sterile | TI-520-08-270-S | Auxein Medical Private Limited | HWC | 08903993114384 |