510(k) K200097 ยท OWI Bone Fixation Cerclage, Sublaminar
Response BandLoc Spinal Fixation
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, Mar 16, 2020 |
| Received | Jan 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200097
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.