Cleared Traditional

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 · SeaSpine Orthopedics Corporation · Orthopedic

Apr 2024

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K232566 is an FDA 510(k) clearance for the 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 Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by SeaSpine Orthopedics Corporation (Carlsbad, US). The FDA issued a Cleared decision on April 19, 2024, 239 days after receiving the submission on August 24, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K232566 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2023
Decision Date	April 19, 2024
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	NKB — Thoracolumbosacral Pedicle Screw System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3070
Definition	Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.