The following data is part of a premarket notification filed by Augmedics Ltd. with the FDA for Xvision Spine System.
| Device ID | K220905 |
| 510k Number | K220905 |
| Device Name: | Xvision Spine System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Augmedics Ltd. 1 Ha-Tsmikha St Yokneam Illit, IL 2069205 |
| Contact | Contact Title |
| 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 | 2022-03-28 |
| Decision Date | 2022-11-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290113781016 | K220905 | 000 |
| 07290113781009 | K220905 | 000 |
| 07290113780996 | K220905 | 000 |