510(k) K182489 · KWQ Appliance, Fixation, Spinal Intervertebral Body
4CIS® Pinehurst Anterior Cervical Plate system
| Applicant | Solco Biomedical Co., Ltd., Pyeongtaek, KR |
| Decision | Substantially Equivalent, Jan 16, 2019 |
| Received | Sep 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182489
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.