510(k) K081414 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO CORAL SPINAL SYSTEM
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Jun 17, 2008 |
| Received | May 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K081414
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.