510(k) K080258 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO ENDIUS MINIT POSTERIOR CERVICAL AND UPPER THORACIC FIXATION SYSTEM
| Applicant | Endius, Inc., Plainville MA, US |
| Decision | Substantially Equivalent, Mar 10, 2008 |
| Received | Jan 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080258
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.