510(k) K100122 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
MODIFICATION TO CAPSURE PS SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Feb 12, 2010 |
| Received | Jan 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100122
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.