Cleared Special

Mariner Pedicle Screw System

K212692 · SeaSpine Orthopedics Corporation · Orthopedic

Sep 2021

Decision

27d

Days

Class 2

Risk

About This 510(k) Submission

K212692 is an FDA 510(k) clearance for the Mariner Pedicle Screw 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 21, 2021, 27 days after receiving the submission on August 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K212692 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2021
Decision Date	September 21, 2021
Days to Decision	27 days
Submission Type	Special
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.