510(k) K231834 ยท GWO Plate, Cranioplasty, Preformed, Alterable
VSP PEEK Cranial Implant
| Applicant | 3D Systems, Inc., Littleton CO, US |
| Decision | Substantially Equivalent, Apr 4, 2024 |
| Received | Jun 22, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231834
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.