510(k) K161535 · NKB Thoracolumbosacral Pedicle Screw System
SeaSpine® NewPort Spinal System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 8, 2016 |
| Received | Jun 3, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161535
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.