510(k) K121615 ยท MNI Orthosis, Spinal Pedicle Fixation
4CIS VANE SPINE SYSTEM
| Applicant | Solco Biomedical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Aug 15, 2012 |
| Received | Jun 1, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121615
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.