Cleared Traditional

Mariner RDX System

K222110 · SeaSpine Orthopedics Corporation · Orthopedic

Sep 2022

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K222110 is an FDA 510(k) clearance for the 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 September 7, 2022, 51 days after receiving the submission on July 18, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K222110 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2022
Decision Date	September 07, 2022
Days to Decision	51 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.