510(k) K200281 ยท OWI Bone Fixation Cerclage, Sublaminar
The Gecko Spinal System
| Applicant | Ortho Development Corporation, Draper UT, US |
| Decision | Substantially Equivalent, Mar 31, 2020 |
| Received | Feb 4, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200281
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.