510(k) K191576 · NKB Thoracolumbosacral Pedicle Screw System
Mercury® Spinal System, Overwatch® Spinal System
| Applicant | Spinal Elements, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 16, 2019 |
| Received | Jun 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191576
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.