510(k) K222572 · KWQ Appliance, Fixation, Spinal Intervertebral Body
FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM & BALTEUM-ONE Lumbar Plate System
| Applicant | Dio Medical Corporation, East Norriton PA, US |
| Decision | Substantially Equivalent, Oct 18, 2022 |
| Received | Aug 25, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222572
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.