NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
FDA 510(k) clearance K232566 · decided 2024-04-19
Clearance details
- K-number
- K232566
- Device name
- NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
- Applicant
- SeaSpine Orthopedics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-08-24
- Decision date
- 2024-04-19
- Days to decision
- 239 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Carlsbad, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, recall (Z-0751-2025) | SEASPINE ORTHOPEDICS CORPORATION | 2024-12-23 |
| Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 M recall (Z-0752-2025) | SEASPINE ORTHOPEDICS CORPORATION | 2024-12-23 |