510(k) K043578 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM
| Applicant | Solco Biomedical Co., Ltd., Bethesda MD, US |
| Decision | Substantially Equivalent, Mar 7, 2005 |
| Received | Dec 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043578
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.