Cleared Special

Mercury Spinal System

K151215 · Spinal Elements, Inc. · Orthopedic

Jun 2015

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K151215 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 June 3, 2015, 28 days after receiving the submission on May 6, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3070.

Submission Details

510(k) Number	K151215 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2015
Decision Date	June 03, 2015
Days to Decision	28 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.