The following data is part of a premarket notification filed by Augmedics Ltd. with the FDA for Xvision Spine System (xvs).
| Device ID | K190929 |
| 510k Number | K190929 |
| Device Name: | Xvision Spine System (XVS) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Augmedics Ltd. 1 Ha-Tsmikha St Yokneam Lllit, IL 2069205 |
| Contact | Tami Harel |
| Correspondent | Janice M. Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-09 |
| Decision Date | 2019-12-20 |