510(k) K080313 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO EXPEDIUM SPINE SYSTEM
| Applicant | Depuy Spine, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, May 8, 2008 |
| Received | Feb 6, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080313
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.