510(k) K161114 ยท NDN Cement, Bone, Vertebroplasty
HIGH V+
| Applicant | Teknimed Sas, L'Union, FR |
| Decision | Substantially Equivalent, Apr 12, 2017 |
| Received | Apr 20, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2023 | TEKNIMED SAS HIGH V+ Spinal Cement System REF T040321K Open, Classified |
NDN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.