510(k) K222110 ยท NKB Thoracolumbosacral Pedicle Screw System
Mariner RDX System
| Applicant | SeaSpine Orthopedics Corporation, Carlsbad CA, US |
| Decision | Substantially Equivalent, Sep 7, 2022 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2024 | SEASPINE ORTHOPEDICS CORPORATION Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. Open, Classified |
NKB | None listed |
| Apr 22, 2024 | SEASPINE ORTHOPEDICS CORPORATION Mariner RDX Polyaxial Head, REF: MX1-000020;
Mariner RDX Extended Polyaxial Head, REF: MX1-000030;
Mariner RDX Deformity Head, REF: MX1-000040;
Mariner RDX Extended Deformity Head, REF: MX1-000050;
Ma Open, Classified |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.