Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K211188
xvision Spine system (XVS) · Augmedics, Ltd. · decided 2021-07-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Perc Insertion Cap | AMCH07320 | AUGMEDICS LTD | SBF | 07290113780866 |
| Perc Slap Hammer | AMCH07370 | AUGMEDICS LTD | SBF | 07290113780873 |
| Perc Pin 125mm 5 units Package | AMCH07012 | AUGMEDICS LTD | SBF | 17290113780931 |
| Perc Mallet 250 gr. | AMCH07700 | AUGMEDICS LTD | SBF | 07290113780880 |
| Perc Pin 150mm 5 units Package | AMCH07015 | AUGMEDICS LTD | SBF | 17290113780924 |
| Augmedics WS-Cart assembly | ACC00401 | AUGMEDICS LTD | SBF | 07290113781061 |
| Perc Schanz Screw Adaptor Short | AMCH07500 | AUGMEDICS LTD | SBF | 07290113780897 |
| 8” Tablet Docking | ACC00302 | AUGMEDICS LTD | OLO | 07290113780729 |
| Perc Pin 100mm 5 units Package | AMCH07010 | AUGMEDICS LTD | SBF | 17290113780948 |
| Rotating Marker Adaptor | AMCH00039 | AUGMEDICS LTD | SBF | 07290113780965 |
| XVS STERILE COMPONENTS KIT | ASP00050 | AUGMEDICS LTD | SBF | 07290113780989 |
| 8” Tablet | ACC00310 | AUGMEDICS LTD | OLO | 07290113780712 |
| Perc Pin Adaptor | AMCH07200 | AUGMEDICS LTD | SBF | 07290113780910 |
| Schanz Screw Adaptor Long | AMCH07550 | AUGMEDICS LTD | SBF | 07290113780903 |
| Perc Pin Tray | AMCH07100 | AUGMEDICS LTD | SBF | 07290113780859 |
| XVS MARKERS WITH XLINK KIT | ASP00047 | AUGMEDICS LTD | SBF | 17290113780979 |
| XVISION Instrument Tray | ASP00044 | AUGMEDICS LTD | SBF | 07290113780958 |