510(k) K211188 ยท SBF Orthopedic Augmented Reality
xvision Spine system (XVS)
| Applicant | Augmedics, Ltd., Yokneam Illit, IL |
| Decision | Substantially Equivalent, Jul 19, 2021 |
| Received | Apr 20, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 13, 2025 | Augmedics Ltd. Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle scre Open, Classified |
OLO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.