510(k) K163489 ยท HWC Screw, Fixation, Bone
OrthoSolutions 'System26' Bone Screws
| Applicant | Ortho Solutions UK Limited, Maldon, GB |
| Decision | Substantially Equivalent, Mar 8, 2017 |
| Received | Dec 12, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163489
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2017 | ORTHO SOLUTIONS, LTD. SYSTEM 26. Part Numbers:
OS900035-NS;
OS900036-NS;
OS900037-NS;
OS900038-NS;
OS900040-NS;
OS900041-NS;
OS900042-NS;
OS900043-NS;
OS900047-NS;
OS900048-NS;
OS900045-NS;
OS900046-NS;
OS900050-NS;
OS9000 Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.