510(k) K111913 ยท MNI Orthosis, Spinal Pedicle Fixation
CAPSURE(R) PS SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Aug 31, 2011 |
| Received | Jul 6, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111913
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.