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
K232566 is the FDA 510(k) clearance record for 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, a class II device, cleared for SeaSpine Orthopedics Corporation on under FDA product code NKB (Thoracolumbosacral Pedicle Screw System). FDA's definition for product code NKB reads: "Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion". FDA records list 67 510(k) clearances for SeaSpine Orthopedics Corporation, from to . As of , FDA records show 2 recalls naming K232566.
Clearance record
- Decision date
- Received
- (239 days to decision)
- Product code
- NKB Thoracolumbosacral Pedicle Screw System
- Regulation
- 21 CFR 888.3070
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- SeaSpine Orthopedics Corporation 5770 Armada Dr., Carlsbad TX
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code NKB
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 1 |
| December 2025 | 2 |
| January 2026 | 3 |
| February 2026 | 3 |
| March 2026 | 0 |
| April 2026 | 5 |
| May 2026 | 4 |
| June 2026 | 2 |
| July 2026 | 4 |
| August 2026 | 0 |
| September 2026 | 5 |
| October 2026 | 0 |
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