The following data is part of a premarket notification filed by Auxein Medical Private Limited with the FDA for Auxilock Titanium Interference Screw.
| Device ID | K203029 |
| 510k Number | K203029 |
| Device Name: | Auxilock Titanium Interference Screw |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-02 |
| Decision Date | 2021-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08903993458051 | K203029 | 000 |
| 08903993457931 | K203029 | 000 |
| 08903993457924 | K203029 | 000 |
| 08903993457917 | K203029 | 000 |
| 08903993457900 | K203029 | 000 |
| 08903993457894 | K203029 | 000 |
| 08903993457887 | K203029 | 000 |
| 08903993457870 | K203029 | 000 |
| 08903993457863 | K203029 | 000 |
| 08903993457948 | K203029 | 000 |
| 08903993457955 | K203029 | 000 |
| 08903993457962 | K203029 | 000 |
| 08903993458044 | K203029 | 000 |
| 08903993458037 | K203029 | 000 |
| 08903993458020 | K203029 | 000 |
| 08903993458013 | K203029 | 000 |
| 08903993458006 | K203029 | 000 |
| 08903993457993 | K203029 | 000 |
| 08903993457986 | K203029 | 000 |
| 08903993457979 | K203029 | 000 |
| 08903993457856 | K203029 | 000 |