Cleared Special

Mariner Deformity System

K211606 · SeaSpine Orthopedics Corporation · Orthopedic

Jun 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K211606 is an FDA 510(k) clearance for the Mariner Deformity 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 June 23, 2021, 29 days after receiving the submission on May 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K211606 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 25, 2021
Decision Date	June 23, 2021
Days to Decision	29 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.