510(k) K053336 ยท NDN Cement, Bone, Vertebroplasty
STAXX FX SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Jul 3, 2006 |
| Received | Dec 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053336
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.