510(k) K232566

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 by SeaSpine Orthopedics Corporation — Product Code NKB

K232566 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "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". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. SeaSpine Orthopedics Corporation has at least 10 other 510(k) clearances on record.