510(k) K192145 ยท PLR Spinal Vertebral Body Replacement Device - Cervical
Galileo Vertebral Body Replacement Device
| Applicant | Bright Spine, Boca Raton FL, US |
| Decision | Substantially Equivalent, Apr 21, 2020 |
| Received | Aug 8, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192145
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.