510(k) K100970 ยท NKB Thoracolumbosacral Pedicle Screw System
STAINLESS STEEL SPINAL SYSTEM
| Applicant | Theken Spine, LLC, Akron OH, US |
| Decision | Substantially Equivalent, Aug 12, 2010 |
| Received | Apr 8, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100970
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.