510(k) K211606 ยท NKB Thoracolumbosacral Pedicle Screw System
Mariner Deformity System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 23, 2021 |
| Received | May 25, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | SEASPINE ORTHOPEDICS CORPORATION SeaSpine Mariner Deformity
Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm
REF: MD1-300010-12 Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.