The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Auxein Nailing System.
| Device ID | K210792 |
| 510k Number | K210792 |
| Device Name: | Auxein Nailing System |
| Classification | Screw, Fixation, Bone |
| Applicant | Auxein Medical Private Limited Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, IN 131028 |
| Contact | Rahul Luthra |
| Correspondent | Rahul Luthra Auxein Medical Private Limited Plot No.168,169,170 Phase-IV, Sector 57, Kundli Industrial Area Sonipat, IN 131028 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-08-25 |