The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Humerus & Ulna System.
| Device ID | K213108 |
| 510k Number | K213108 |
| Device Name: | Humerus & Ulna System |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-24 |
| Decision Date | 2022-11-04 |