Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K250255
xvision Spine system · Augmedics, Ltd. · decided 2025-03-13 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| XVS C L-Headset IPD-60 Clear Display | AHMD602CLT | AUGMEDICS LTD | SBF | 07290113781399 |
| Tall Straight Clamp | AMCH07303 | AUGMEDICS LTD | SBF | 07290113781634 |
| XVS C Headset IPD-68 LCD Display | AHMD681CLD | AUGMEDICS LTD | SBF | 07290113781290 |
| PC Mouse | ACC00419 | AUGMEDICS LTD | SBF | 07290113781672 |
| Standard perc pin tray, instruments included | AMCH00052 | AUGMEDICS LTD | SBF | 07290113781665 |
| XVS C Headset IPD-60 LCD Display | AHMD601CLD | AUGMEDICS LTD | SBF | 07290113781252 |
| Perc Pin Adaptor | AMCH07304 | AUGMEDICS LTD | SBF | 07290113781641 |
| Standard xvision tray, instruments included | AMCH00051 | AUGMEDICS LTD | SBF | 07290113781658 |
| XVS C Headset IPD-68 Clear Display | AHMD681CLT | AUGMEDICS LTD | SBF | 07290113781351 |
| XVS C L-Headset IPD-68 Clear Display | AHMD682CLT | AUGMEDICS LTD | SBF | 07290113781474 |
| XVS C Headset IPD-60 Clear Display | AHMD601CLT | AUGMEDICS LTD | SBF | 07290113781313 |
| XVS C L-Headset IPD-64 Clear Display | AHMD642CLT | AUGMEDICS LTD | SBF | 07290113781436 |
| XVS C Headset IPD-64 LCD Display | AHMD641CLD | AUGMEDICS LTD | SBF | 07290113781276 |
| C-arm Ring Adaptor | AMCH07619 | AUGMEDICS LTD | SBF | 07290113781122 |
| Straight Clamp | AMCH07301 | AUGMEDICS LTD | SBF | 07290113781610 |
| Patient Marker Extender | AMCH00048 | AUGMEDICS LTD | SBF | 07290113781115 |
| XVS C L-Headset IPD-60 LCD Display | AHMD602CLD | AUGMEDICS LTD | SBF | 07290113781375 |
| Arc Clamp | AMCH07302 | AUGMEDICS LTD | SBF | 07290113781627 |
| XVS C Headset IPD-64 Clear Display | AHMD641CLT | AUGMEDICS LTD | SBF | 07290113781337 |
| XVS C L-Headset IPD-64 LCD Display | AHMD642CLD | AUGMEDICS LTD | SBF | 07290113781412 |
| XVS C L-Headset IPD-68 LCD Display | AHMD682CLD | AUGMEDICS LTD | SBF | 07290113781450 |
| XVS MARKERS WITH C-LINK KIT 3 SETS PACK | ASP07070 | AUGMEDICS LTD | SBF | 17290113781181 |
| XVS MARKERS FOR ASC KIT 3 SETS PACK | ASP07073 | AUGMEDICS LTD | SBF | 17290113781150 |