510(k) K191648 ยท NKB Thoracolumbosacral Pedicle Screw System
Mariner MIS Pedicle Screw System; SeaSpine Navigation System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jul 19, 2019 |
| Received | Jun 20, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191648
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.