510(k) K083353 ยท MNI Orthosis, Spinal Pedicle Fixation
CAPSURE(R) PS SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Dec 11, 2008 |
| Received | Nov 13, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083353
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.