510(k) K191047 ยท PLF Bone Wedge
ADI TiDAL Osteotomy Wedge
| Applicant | Additive Device, Inc. (Adi) D/B/A Restor3D, Durham NC, US |
| Decision | Substantially Equivalent, Nov 5, 2019 |
| Received | Apr 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191047
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.