510(k) K200846 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Balteum Lumbar Plate System
| Applicant | Huvexel Co. , Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, May 5, 2020 |
| Received | Mar 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200846
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.