510(k) K081228 ยท MNI Orthosis, Spinal Pedicle Fixation
CAPSURE PS (R) SPINE SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, May 12, 2008 |
| Received | Apr 30, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081228
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.