510(k) K172101 · NKB Thoracolumbosacral Pedicle Screw System
ROMEO® 2 Posterior Osteosynthesis System
| Applicant | Spineart, Plan Les Ouates, CH |
| Decision | Substantially Equivalent, Sep 26, 2017 |
| Received | Jul 12, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172101
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.