510(k) K063606 ยท OBL Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
MODIFICATION TO STAXX FX SYSTEM
| Applicant | Spine Wave, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Apr 13, 2007 |
| Received | Dec 1, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063606
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.