510(k) K190289 · OWI Bone Fixation Cerclage, Sublaminar
Karma® Fixation System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Feb 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190289
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.