510(k) K213820 · KWQ Appliance, Fixation, Spinal Intervertebral Body
BALTEUM - ONE Lumbar Plate System
| Applicant | Huvexel Co. , Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Mar 25, 2022 |
| Received | Dec 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213820
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.