The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Auxilock Gfs Mini, Gfs Ii Large, And Gfs Ultimate.
| Device ID | K213018 |
| 510k Number | K213018 |
| Device Name: | Auxilock GFS Mini, GFS II Large, And GFS Ultimate |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| 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 | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-20 |
| Decision Date | 2022-11-18 |