510(k) K081145 ยท MNI Orthosis, Spinal Pedicle Fixation
MODIFICATION TO 4CIS VANE SPINE SYSTEM
| Applicant | Solco Biomedical Co., Ltd., Rockville MD, US |
| Decision | Substantially Equivalent, Nov 5, 2008 |
| Received | Apr 22, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081145
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.