The following data is part of a premarket notification filed by Augmedics Ltd with the FDA for Xvision Spine System (xvs).
| Device ID | K211188 |
| 510k Number | K211188 |
| Device Name: | Xvision Spine System (XVS) |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Augmedics Ltd 1 Ha-Tsmikha St Yokneam Illit, 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 | 2021-04-20 |
| Decision Date | 2021-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 27290113780976 | K211188 | 000 |
| 17290113780986 | K211188 | 000 |
| 07290113780712 | K211188 | 000 |
| 07290113780729 | K211188 | 000 |
| 07290113780859 | K211188 | 000 |
| 07290113780866 | K211188 | 000 |
| 07290113780873 | K211188 | 000 |
| 07290113780880 | K211188 | 000 |
| 07290113780897 | K211188 | 000 |
| 07290113780903 | K211188 | 000 |
| 07290113780910 | K211188 | 000 |
| 07290113780958 | K211188 | 000 |
| 07290113780965 | K211188 | 000 |
| 27290113780921 | K211188 | 000 |
| 27290113780938 | K211188 | 000 |
| 27290113780945 | K211188 | 000 |
| 07290113781061 | K211188 | 000 |