Mariner RDX System
FDA 510(k) clearance K222110 · decided 2022-09-07
Clearance details
- K-number
- K222110
- Device name
- Mariner RDX System
- Applicant
- SeaSpine Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2022-07-18
- Decision date
- 2022-09-07
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments recall (Z-1620-2024) | SEASPINE ORTHOPEDICS CORPORATION | 2024-04-23 |
| Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1 recall (Z-1605-2024) | SEASPINE ORTHOPEDICS CORPORATION | 2024-04-22 |