Cleared Traditional

Mercury? Spinal System

K172967 · Spinal Elements, Inc. · Orthopedic

Apr 2018

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K172967 is an FDA 510(k) clearance for the Mercury? Spinal System, a Thoracolumbosacral Pedicle Screw System (Class II — Special Controls, product code NKB), submitted by Spinal Elements, Inc. (Carlsbad, US). The FDA issued a Cleared decision on April 10, 2018, 196 days after receiving the submission on September 26, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K172967 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2017
Decision Date	April 10, 2018
Days to Decision	196 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.